TBD Meeting (2931-11)

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin's presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin's presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin's presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin’s presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin’s presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – A 9-mm wheal after skin prick testing provided a 95% positive predictive value for egg or peanut allergy in an analysis of data from 5,000 12-month-old infants recruited from the general population.

The current clinical practice of diagnosing peanut or egg allergy in infants who develop wheals larger than 8 mm from skin prick testing is appropriate in the general population, Lyle Gurrin, Ph.D., and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Infants with a wheal of any size after a skin prick test were invited for a diagnostic oral food challenge unless they had a convincing reaction in the previous month.

The analysis included 181 infants who underwent peanut challenges, 310 with egg challenges, and 71 with sesame challenges. None of the wheal sizes after sesame challenges reached a 95% positive predictive value for allergy, said Dr. Gurrin of the University of Melbourne.

Previous studies have suggested skin-prick-test wheal sizes provide a 95% likelihood of food allergy if the wheal is 8 mm or larger for egg allergy and 7 mm or larger for peanut allergy. Most of those were small studies of high-risk patients drawn from clinics, not the general population. The studies included a broad range of ages and relied on a history of ingestion reaction rather than performing a formal food challenge.

The current analysis used data from the larger HealthNuts study, a population-based study of Australian 1-year-old infants that was conducted to identify the prevalence of food allergy and modifiable risk factors. Investigators recruited parents and infants at childhood immunization sessions, and 2,848 (73%) agreed to participate. Skin prick tests showed sensitization (a wheal of 1 mm or larger) to peanut in 9%, to raw egg white in 16%, and to sesame in 3% (J. Allergy Clin. Immunol. 2011;127:668-676.e2).

Oral food challenges in these sensitized patients proved that 3% of the entire cohort was allergic to peanut, 9% was allergic to raw egg 1%, and had sesame allergy. Of the infants with raw egg allergy, 80% were able to tolerate baked egg. Some infants were allergic to more than one food. Overall, more than 10% of the cohort had challenge-proven IgE-mediated allergy to one of the common allergenic foods of childhood.

Further analysis of wheal-size thresholds for diagnosis will stratify the findings by the presence or absence of eczema, a family history of allergy, and the ingestion/reaction history, Dr. Gurrin said.

A positive oral food challenge was defined as three or more concurrent, noncontact urticaria lasting at least 5 minutes, vomiting, periorbital angioedema, or anaphylaxis occurring within 2 hours of ingesting the test food.

No patients were excluded from the HealthNuts study due to severe eczema, said one of Dr. Gurrin’s study associates, Dr. Katrina Allen, also of the university.

Less than 1% of infants in the study were dark skinned, but demographic factors did not differ significantly between infants who were excluded from the study and those who were enrolled, she said during the question-and-answer session after Dr. Gurrin’s presentation.

The demographic characteristics of infants in the HealthNuts study were similar to population data from the Perinatal Data Collection Unit, but the mothers of HealthNuts infants tended to be older than in the general population.

A brief questionnaire completed by parents who declined to participate in the HealthNuts study suggested that nonparticipating infants were less likely to have a family history of allergy and more likely to already be eating and tolerating peanuts.

The study was funded by the Australian National Health and Medical Research Council, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the U.S. Department of Defense, and the Australian Egg Corp. Dr. Gurrin and Dr. Allen said they had no relevant financial disclosures.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – Overweight inner-city teenagers with nonobstructive asthma were more likely than their normal-weight peers to report that their asthma was out of control even when spirometry results suggested they were having a relatively good day, a study of 114 teens found.

The study included 102 normal-weight adolescents and 112 overweight adolescents (defined as a body mass index greater than the 85th percentile) who completed the Asthma Control Test and spirometry measures. Observed lung function was similar between the two groups, Iwalola Awoyinka and her associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, the overweight teenagers were more likely than the normal-weight teenagers to report uncontrolled asthma on the Asthma Control Test. When compared by asthma pattern, however, only teens with nonobstructive asthma were significantly more likely to report uncontrolled asthma (in more than 60%), compared with normal-weight teens with nonobstructive asthma, approximately 50% of whom reported uncontrolled asthma.

Among teens with an obstructive asthma pattern, reports of uncontrolled asthma were statistically similar between the overweight and normal-weight groups, hovering around 60%, said Ms. Awoyinka, a pulmonary function specialist and research coordinator at the University of Wisconsin, Madison.

What some overweight teens perceive as uncontrolled asthma may be a symptom of deconditioning, Ms. Awoyinka suggested. Misperceptions of uncontrolled asthma may lead to overuse of asthma medication. Perhaps prescriptions for overweight teens with asthma should include prescriptions to exercise, she added in an interview.

Uncontrolled asthma, defined as a score of 19 or less on the Asthma Control Test, was reported by 131 adolescents. Spirometry identified 99 teens as having nonobstructive asthma and 115 as having an obstructive asthma pattern, defined as less than 80% of predicted forced expiratory volume in 1 second (FEV₁) or a ratio of FEV₁ to forced vital capacity (FVC) of less than 0.85.

The analysis was part of a larger study of the use of electronic technology to improve asthma control in 218 inner-city teens on Medicaid, 4 of whom were excluded from the analysis because of a lack of acceptable spirometry results. Previous studies have shown that teens with low socioeconomic status are more likely to be overweight and to have asthma than are more affluent teens.

The National Institutes of Health funded the study. The investigators reported having no relevant conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – A collaborative, community-based program to improve care for publicly insured children has reduced emergency department visits, hospitalizations, and costs, thanks in large part to a strong focus on asthma care.

Dr. Tom Peterson and his associates emulated a similar program at Denver Children’s Hospital to start the Children’s Healthcare Access Program (CHAP) for pediatric Medicaid recipients in Grand Rapids, Mich. Their 3-year-old program has been so successful that other Michigan counties are now copying it.

"It’s not just an asthma program, but asthma is the biggest and most collaborative project we’ve pulled together" in CHAP, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In its first 3 years, CHAP connected almost 2,000 new Medicaid patients with clinicians and helped those clinicians access approximately $500,000 in provider incentives such as pay-for-performance incentives, he said. Of the approximately 15,300 children covered by CHAP, almost 6,000 were referred for CHAP services, including transportation for patients who might otherwise be no-shows for appointments.

In the CHAP population overall, emergency department visits decreased by 12% and hospitalizations decreased by 14%, reported Dr. Peterson, a pediatrician and executive director of safety, quality, and community health at Helen DeVos Children’s Hospital, Grand Rapids. Much greater decreases were seen in teaching clinics involved in CHAP.

Previous research by Dr. Peterson showed that children with public insurance or no insurance in Michigan were twice as likely to have asthma as were privately insured children (J. Pediatrics 2011;158:313-8.e2).

His hospital partnered with the Asthma Network of West Michigan and a managed care organization to pull together a group consisting of 40 pediatricians; 10-12 family physicians; and midlevel providers from four private practices, nine community- and school-based clinics, a pediatric resident teaching clinic, and a nurse practitioner clinic in CHAP.

The program features a team of six or seven people who help improve the children’s "medical homes" in primary care practices and help clinicians by coordinating the care. "Education is a significant piece of this, not just for the families but also for providers, sites, and patients," Dr. Peterson said.

CHAP can help practices improve efficiencies and scheduling. It helps coordinate care with mental health services, transportation, and other services. Education covers not just asthma but also flu shots, diet and nutrition, and inappropriate use of emergency departments. CHAP also acts as a neutral convener of meetings with community stakeholders (some of whom had never met together) to address systemic issues.

The asthma program within CHAP provides ongoing education and training of health care providers, families, and patients. High-risk children get monthly home-based visits for disease management for the first 6 months, then two visits in the next 6 months. CHAP pays attention to transitions of care between inpatient stays and medical homes, and now includes schools in postdischarge care. Services currently are provided by four certified, culturally skilled, multilingual asthma educators and two social workers, who may visit families to assist with psychosocial barriers to asthma care. CHAP also provides funding for home-based asthma case management through the Asthma Network of West Michigan.

Among seven high-risk children with asthma in CHAP’s case-management program, emergency department visits have decreased by 30% and hospitalizations have decreased by 63%, he said.

CHAP’s asthma team includes five pediatricians, asthma educators, an asthma and allergy specialist, school leaders or nurses, Medicaid health plan representatives and case managers, the Children’s Hospital quality improvement specialist, CHAP’s medical director and manager, and data analysts. "It’s a pretty diverse group of people to get together," Dr. Peterson said.

The CHAP team assesses participating medical practices for 12 characteristics "that we think constitute a really good asthma site," he said. These include asthma in-service training for staff and education for patients, having an in-office asthma educator, referring appropriate patients to CHAP or the Asthma Network of West Michigan, teaching peak flow monitoring, assessing exposure to environmental tobacco, in-office spirometry, use of management plans, the Asthma Control Test and an asthma registry, and routine 6-month asthma visits.

With 1 point allotted for each of the 12 factors, the average score of CHAP practices increased from 6 to 10 in the first 3 years of the program.

Priority Health, a managed care organization, provided kits for the program. CHAP is funded by the hospital and by a variety of private and corporate foundations, including the Douglas and Maria DeVos Foundation, W.K. Kellogg Foundation, Steelcase Foundation, Sebastian Foundation, Early Childhood Investment Corporation, Frey Foundation, Grand Rapids Community Foundation, Heart of West Michigan United Way, O’Donovan Family Foundation, and PNC Grow Up Great. Dr. Peterson said he has no conflicts of interest.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – Intermittent courses of high-dose inhaled budesonide were as effective and as safe as daily low-dose inhaled budesonide in wheezing toddlers but exposed them to a lower cumulative dose of the corticosteroid in a year-long study of 278 children.

The two groups did not differ significantly in the frequency of exacerbations that required systemic corticosteroids, the frequency or severity of respiratory tract illness, the number of urgent or emergent visits for care, or other efficacy and safety measures, Dr. Leonard B. Bacharier and his associates reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children in the daily low-dose budesonide group, however, were exposed to more than three times the cumulative dose of budesonide, compared with the intermittent high-dose therapy group – 150 mg vs. 46 mg.

The multicenter, randomized, double-blind, placebo-controlled trial, called the Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) study, is the last of eight clinical trials performed by the National Heart, Lung, and Blood Institute’s Childhood Asthma Research and Education Network.

The NHLBI’s 2007 "Expert Panel Report 3: Guidelines for Diagnosis and Management of Asthma" recommended using daily low-dose inhaled corticosteroids to treat children who have a positive modified Asthma Predictive Index.

The MIST study is the first to compare the currently recommended daily low-dose regimen with the intermittent high-dose regimen, said Dr. Bacharier of Washington University, St. Louis.

On the basis of the MIST results, Dr. Bacharier and his associates recommended instead that clinicians consider using intermittent high-dose inhaled corticosteroids in the subset of children identified in the MIST study, who were not the most severe asthma cases. They suggested starting a 7-day course of high-dose budesonide early during respiratory tract illnesses in wheezing children who have a positive modified Asthma Predictive Index, have had at least one exacerbation in the past year, use albuterol less than 3 days per week, and have had no more than one night awakening in the prior 2 weeks.

The study enrolled children 12-53 months of age, nearly half of whom were in the lower age range of 12-32 months. All children had a history of at least four wheezing episodes in the prior year (or at least three if they’d had 3 months or more of asthma controller therapy) and a positive modified Asthma Predictive Index. Each child also had at least one severe exacerbation that required systemic corticosteroids or an unscheduled urgent or emergent visit or hospitalization in the previous year.

The study excluded children who had more than two hospitalizations for wheezing or more than six courses of oral corticosteroids.

During a 2-week run-in period, all children used a nebulized placebo nightly and albuterol as needed. During this period, children who had persistent asthma symptoms or who did not follow the protocol for more than 25% of days also were excluded.

The children were then randomized for 52 weeks of therapy. The daily low-dose budesonide group used 0.5 mg of nebulized budesonide once daily at night except during respiratory tract illness, when they switched to "respiratory tract illness kits" that gave them nebulized placebo in the morning and 0.5 mg of budesonide at night for 7 days. The intermittent high-dose budesonide group used nebulized placebo once daily at night except during respiratory tract illness, when their kits gave them 1 mg of budesonide in the morning and at night for 7 days.

Previous studies have shown that daily inhaled corticosteroids have "a small but statistically significant class effect on reducing linear growth in preschool-aged children, which only partially reverses after discontinuation of study treatments," which was a main reason for studying the intermittent-therapy alternative, Dr. Bacharier said.

In the MIST study, children in the daily-therapy group grew an average of 7.76 cm, compared with 8.01 cm in the intermittent-therapy group, but the 0.25-cm greater growth with intermittent therapy was not statistically significant.

There were no significant differences between groups in baseline characteristics, adherence to therapy during the study, declines in levels of exhaled nitric oxide, time to first exacerbation, or time to treatment failure.

The NHLBI funded the study. AstraZeneca provided the budesonide and placebo for the study. Dr. Bacharier has been a consultant for AstraZeneca (which markets budesonide), Merck, and Novartis, and has received honoraria from GlaxoSmithKline.

SAN FRANCISCO – The experimental drug icatibant relieved moderate or severe acute attacks of hereditary angioedema faster than placebo in the third randomized, double-blind, controlled trial of the experimental drug in 98 patients.

Among 88 patients with cutaneous and/or abdominal acute attacks, the 43 patients randomized to treatment with a single subcutaneous injection of 30 mg of icatibant reported that symptom relief started a median of 2 hours after treatment, compared with 20 hours for the 45 patients randomized to saline placebo injection. Symptom relief was defined as at least a 50% decrease in the combined Visual Analog Scale (VAS) symptom score, compared with baseline.

"I think this represents a very exciting, important advance in the treatment of an underserved population," Dr. William R. Lumry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A significant difference between groups was seen as early as 1 hour after treatment, but the 50% or greater reduction in VAS symptom scores was not achieved until 2 hours after treatment, Dr. Lumry and his associates reported.

The third For Angioedema Subcutaneous Treatment (FAST-3) trial followed two earlier phase III trials of the drug for acute attacks of hereditary angioedema, FAST-1 and FAST-2 (N. Engl. J. Med. 2010;363:532-41).

A "not approvable" letter from the Food and Drug Administration prompted Shire, the company developing icatibant, to provide more data to the FDA. The company’s response and results from FAST-3 are scheduled to be reviewed by the FDA in August 2011.

The FAST-3 study enrolled adults in 11 countries with moderate to very severe swelling from type I or type II hereditary angioedema that had been going on for no more than 12 hours and included at least one VAS score of 30 mm or greater. Patients were observed for 8 hours after injection, and their skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice changes were assessed every 30 minutes for 4 hours after injection and at 5, 6, 8, and 12 hours. Rescue therapy was permitted but withheld if possible for 8-9 hours after injection.

Only the cutaneous and abdominal attacks were considered in the primary results, said Dr. Lumry, medical director of the Allergy and Asthma Research Associates Research Center, Dallas.

The 10 patients with laryngeal swelling attacks provided additional data. Five patients with severe laryngeal attacks immediately received open-label icatibant and reported onset of relief of symptoms a median of 2.3 hours later. Among five patients with mild to moderate laryngeal attacks, three patients who were randomized to icatibant treatment reported onset of symptom relief a median of 2.5 hours after treatment.

The two patients with mild to moderate attacks who were randomized to placebo both ended up getting icatibant, one whose attack was severe enough to warrant treatment, and the other a patient who received icatibant as rescue therapy 3.4 hours after randomization. Combined, the two patients with mild to moderate laryngeal attacks who were randomized to placebo reported onset of symptom relief a median of 3.2 hours after treatment.

Secondary outcomes in the nonlaryngeal cohort were significantly improved in the icatibant group, compared with the placebo group, Dr. Lumry said. The median time to initial symptom relief (assessed by the patients and the investigators) was less than 1 hour in the icatibant group and about 3.5 hours in the placebo group. The median time to onset of relief of the primary symptom (skin pain, skin swelling, or abdominal pain) was 1.5 hours in the icatibant group and 18.5 hours in the placebo group. The median time to almost complete symptom relief was less than 1 hour with icatibant and 36 hours with placebo.

Safety measures were recorded daily for 5 days and at a final 14-day safety visit.

Rescue medications were needed before the onset of symptom relief by 17 patients randomized to placebo – 16 in the nonlaryngeal cohort and 1 in the laryngeal cohort – compared with none in the icatibant groups. In the nonlaryngeal cohort, 3 patients in the icatibant group and 18 in the placebo group used rescue medications at some time during the attack or within 5 days of the injection.

All patients who got icatibant developed injection site reactions that resolved within 4 hours. Of the patients who initially received placebo, 10 developed at least one severe adverse event, compared with 2 patients who were randomized to icatibant and none who received open-label icatibant, a significant difference between the drug and placebo groups. One patient in the placebo group died of a myocardial infarction around 10 days later.

Because many of the adverse events that were most commonly reported are associated with hereditary angioedema, "we could not separate whether this was due to drug effect or due to the attack," Dr. Lumry said.

The mean age of patients in the study’s different arms ranged from 36 to 50 years. Most of the patients were women, and most were white.

The study was funded by Shire, which is developing icatibant. Dr. Lumry has been a consultant or speaker for, or received research grants from, Shire, CSL Behring, Dyax, Pharming, and ViroPharma.

SAN FRANCISCO – The experimental drug icatibant relieved moderate or severe acute attacks of hereditary angioedema faster than placebo in the third randomized, double-blind, controlled trial of the experimental drug in 98 patients.

Among 88 patients with cutaneous and/or abdominal acute attacks, the 43 patients randomized to treatment with a single subcutaneous injection of 30 mg of icatibant reported that symptom relief started a median of 2 hours after treatment, compared with 20 hours for the 45 patients randomized to saline placebo injection. Symptom relief was defined as at least a 50% decrease in the combined Visual Analog Scale (VAS) symptom score, compared with baseline.

"I think this represents a very exciting, important advance in the treatment of an underserved population," Dr. William R. Lumry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A significant difference between groups was seen as early as 1 hour after treatment, but the 50% or greater reduction in VAS symptom scores was not achieved until 2 hours after treatment, Dr. Lumry and his associates reported.

The third For Angioedema Subcutaneous Treatment (FAST-3) trial followed two earlier phase III trials of the drug for acute attacks of hereditary angioedema, FAST-1 and FAST-2 (N. Engl. J. Med. 2010;363:532-41).

A "not approvable" letter from the Food and Drug Administration prompted Shire, the company developing icatibant, to provide more data to the FDA. The company’s response and results from FAST-3 are scheduled to be reviewed by the FDA in August 2011.

The FAST-3 study enrolled adults in 11 countries with moderate to very severe swelling from type I or type II hereditary angioedema that had been going on for no more than 12 hours and included at least one VAS score of 30 mm or greater. Patients were observed for 8 hours after injection, and their skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice changes were assessed every 30 minutes for 4 hours after injection and at 5, 6, 8, and 12 hours. Rescue therapy was permitted but withheld if possible for 8-9 hours after injection.

Only the cutaneous and abdominal attacks were considered in the primary results, said Dr. Lumry, medical director of the Allergy and Asthma Research Associates Research Center, Dallas.

The 10 patients with laryngeal swelling attacks provided additional data. Five patients with severe laryngeal attacks immediately received open-label icatibant and reported onset of relief of symptoms a median of 2.3 hours later. Among five patients with mild to moderate laryngeal attacks, three patients who were randomized to icatibant treatment reported onset of symptom relief a median of 2.5 hours after treatment.

The two patients with mild to moderate attacks who were randomized to placebo both ended up getting icatibant, one whose attack was severe enough to warrant treatment, and the other a patient who received icatibant as rescue therapy 3.4 hours after randomization. Combined, the two patients with mild to moderate laryngeal attacks who were randomized to placebo reported onset of symptom relief a median of 3.2 hours after treatment.

Secondary outcomes in the nonlaryngeal cohort were significantly improved in the icatibant group, compared with the placebo group, Dr. Lumry said. The median time to initial symptom relief (assessed by the patients and the investigators) was less than 1 hour in the icatibant group and about 3.5 hours in the placebo group. The median time to onset of relief of the primary symptom (skin pain, skin swelling, or abdominal pain) was 1.5 hours in the icatibant group and 18.5 hours in the placebo group. The median time to almost complete symptom relief was less than 1 hour with icatibant and 36 hours with placebo.

Safety measures were recorded daily for 5 days and at a final 14-day safety visit.

Rescue medications were needed before the onset of symptom relief by 17 patients randomized to placebo – 16 in the nonlaryngeal cohort and 1 in the laryngeal cohort – compared with none in the icatibant groups. In the nonlaryngeal cohort, 3 patients in the icatibant group and 18 in the placebo group used rescue medications at some time during the attack or within 5 days of the injection.

All patients who got icatibant developed injection site reactions that resolved within 4 hours. Of the patients who initially received placebo, 10 developed at least one severe adverse event, compared with 2 patients who were randomized to icatibant and none who received open-label icatibant, a significant difference between the drug and placebo groups. One patient in the placebo group died of a myocardial infarction around 10 days later.

Because many of the adverse events that were most commonly reported are associated with hereditary angioedema, "we could not separate whether this was due to drug effect or due to the attack," Dr. Lumry said.

The mean age of patients in the study’s different arms ranged from 36 to 50 years. Most of the patients were women, and most were white.

The study was funded by Shire, which is developing icatibant. Dr. Lumry has been a consultant or speaker for, or received research grants from, Shire, CSL Behring, Dyax, Pharming, and ViroPharma.

SAN FRANCISCO – The experimental drug icatibant relieved moderate or severe acute attacks of hereditary angioedema faster than placebo in the third randomized, double-blind, controlled trial of the experimental drug in 98 patients.

Among 88 patients with cutaneous and/or abdominal acute attacks, the 43 patients randomized to treatment with a single subcutaneous injection of 30 mg of icatibant reported that symptom relief started a median of 2 hours after treatment, compared with 20 hours for the 45 patients randomized to saline placebo injection. Symptom relief was defined as at least a 50% decrease in the combined Visual Analog Scale (VAS) symptom score, compared with baseline.

"I think this represents a very exciting, important advance in the treatment of an underserved population," Dr. William R. Lumry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A significant difference between groups was seen as early as 1 hour after treatment, but the 50% or greater reduction in VAS symptom scores was not achieved until 2 hours after treatment, Dr. Lumry and his associates reported.

The third For Angioedema Subcutaneous Treatment (FAST-3) trial followed two earlier phase III trials of the drug for acute attacks of hereditary angioedema, FAST-1 and FAST-2 (N. Engl. J. Med. 2010;363:532-41).

A "not approvable" letter from the Food and Drug Administration prompted Shire, the company developing icatibant, to provide more data to the FDA. The company’s response and results from FAST-3 are scheduled to be reviewed by the FDA in August 2011.

The FAST-3 study enrolled adults in 11 countries with moderate to very severe swelling from type I or type II hereditary angioedema that had been going on for no more than 12 hours and included at least one VAS score of 30 mm or greater. Patients were observed for 8 hours after injection, and their skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice changes were assessed every 30 minutes for 4 hours after injection and at 5, 6, 8, and 12 hours. Rescue therapy was permitted but withheld if possible for 8-9 hours after injection.

Only the cutaneous and abdominal attacks were considered in the primary results, said Dr. Lumry, medical director of the Allergy and Asthma Research Associates Research Center, Dallas.

The 10 patients with laryngeal swelling attacks provided additional data. Five patients with severe laryngeal attacks immediately received open-label icatibant and reported onset of relief of symptoms a median of 2.3 hours later. Among five patients with mild to moderate laryngeal attacks, three patients who were randomized to icatibant treatment reported onset of symptom relief a median of 2.5 hours after treatment.

The two patients with mild to moderate attacks who were randomized to placebo both ended up getting icatibant, one whose attack was severe enough to warrant treatment, and the other a patient who received icatibant as rescue therapy 3.4 hours after randomization. Combined, the two patients with mild to moderate laryngeal attacks who were randomized to placebo reported onset of symptom relief a median of 3.2 hours after treatment.

Secondary outcomes in the nonlaryngeal cohort were significantly improved in the icatibant group, compared with the placebo group, Dr. Lumry said. The median time to initial symptom relief (assessed by the patients and the investigators) was less than 1 hour in the icatibant group and about 3.5 hours in the placebo group. The median time to onset of relief of the primary symptom (skin pain, skin swelling, or abdominal pain) was 1.5 hours in the icatibant group and 18.5 hours in the placebo group. The median time to almost complete symptom relief was less than 1 hour with icatibant and 36 hours with placebo.

Safety measures were recorded daily for 5 days and at a final 14-day safety visit.

Rescue medications were needed before the onset of symptom relief by 17 patients randomized to placebo – 16 in the nonlaryngeal cohort and 1 in the laryngeal cohort – compared with none in the icatibant groups. In the nonlaryngeal cohort, 3 patients in the icatibant group and 18 in the placebo group used rescue medications at some time during the attack or within 5 days of the injection.

All patients who got icatibant developed injection site reactions that resolved within 4 hours. Of the patients who initially received placebo, 10 developed at least one severe adverse event, compared with 2 patients who were randomized to icatibant and none who received open-label icatibant, a significant difference between the drug and placebo groups. One patient in the placebo group died of a myocardial infarction around 10 days later.

Because many of the adverse events that were most commonly reported are associated with hereditary angioedema, "we could not separate whether this was due to drug effect or due to the attack," Dr. Lumry said.

The mean age of patients in the study’s different arms ranged from 36 to 50 years. Most of the patients were women, and most were white.

The study was funded by Shire, which is developing icatibant. Dr. Lumry has been a consultant or speaker for, or received research grants from, Shire, CSL Behring, Dyax, Pharming, and ViroPharma.