Baseline characteristics of children with mild persistent asthma predict response to ICS

Public release date: 22-May-2012
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Contact: Nathaniel Dunford
ndunford@thoracic.org
212-315-8620
American Thoracic Society

ATS 2012, SAN FRANCISCO A further analysis of a previously published National Heart, Lung, and Blood Institute (NHLBI) funded study of children with mild persistent asthma reports the relative benefits of inhaled corticosteroid (ICS) treatment varies among children with differing demographic and clinical characteristics.

"We performed post-hoc data analysis on 288 children enrolled in the TReating Children to Prevent Exacerbations of Asthma (TREXA) study performed by the NHLBI funded Childhood Asthma Research and Education (CARE) Network," said Lynn Gerald, PhD, MSPH, professor in the Department of Health Promotion Sciences and associate dean of research in the College of Public Health at the University of Arizona. "Our findings suggest that all children with mild persistent asthma benefit from ICS treatment, but some groups benefit more than others."

The TREXA trial compared four ICS treatment strategies: daily treatment (daily), daily treatment plus symptom-targeted treatment (combined), symptom-targeted only treatment (rescue), and placebo. Daily treatment, but not combined or rescue treatment, reduced the time to first exacerbation compared with placebo, and all three strategies reduced treatment failures. Time to treatment failure was defined as time to an oral corticosteroid-requiring exacerbation and treatment failure was defined as experiencing two or more oral corticosteroid-requiring exacerbations.

In post-hoc subgroup analyses using either time to first exacerbation or time to treatment failure as an outcome, children in the daily and combined groups who were younger (6-11 yrs versus 12-17 years), were non-Hispanic, had eczema, were skin test positive, and who had IgE levels >185K/uL experienced treatment benefit as compared to those assigned to placebo. Among children assigned to the rescue group, the results were similar to those above when using time to treatment failure as an outcome; however, when using time to first exacerbation as an outcome, only those with eczema, high IgE levels, and less than perfect asthma control during the run-in period were demonstrated to benefit when compared to placebo.

"Our study indicates that some groups of children with mild persistent asthma have greater exacerbation risk than others and therefore have more to gain from ICS treatment for reducing this risk," said Dr. Gerald. "These findings need to be validated in future studies."

###

"Predictors Of Response To Inhaled Corticosteroids: Stratified Results From The TREXA Trial" (Session C27, Tuesday, May 22, 2012: 8:15-10:45 a.m., Room 2010-2012, Moscone Center; Abstract 26378)

* Please note that numbers in this release may differ slightly from those in the abstract. Many of these investigations are ongoing; the release represents the most up-to-date data available at press time.

Abstract 26378
Predictors Of Response To Inhaled Corticosteroids: Stratified Results From The TREXA Trial
Type: Scientific Abstract
Category: 14.02 - Pediatric Asthma (PEDS)
Authors: L.B. Gerald1, J.K. Gerald1, N. Graber2, V. Chinchilli2, F.J. Martinez1; 1University of Arizona - Tucson, AZ/US, 2Penn State - Hershey, PA/US; TREXA Study Group

Abstract Body

Introduction: When taken daily, inhaled corticosteroids (ICSs) reduce exacerbations among children with mild persistent asthma. The TREXA trial compared 4 ICS treatment strategies: daily treatment (daily), daily treatment plus symptom-targeted treatment (combined), symptom-targeted only treatment (rescue), and placebo. Compared to placebo, daily treatment, but not combined or rescue treatment reduced the time to first exacerbation (TFE); however, all 3 strategies reduced treatment failures. Stratified analyses identifying subgroups most responsive to ICS treatment are presented here.

Methods: In this 44-week, randomized, double-blinded, placebo-controlled trial, children and adolescents 5? years of age with mild persistent asthma were enrolled from 5 clinical centers across the US. Participants were randomly assigned to 1 of 4 treatment groups: daily ICS plus symptom-targeted ICS (combined), daily ICS only (daily), symptom-targeted ICS only (rescue), and placebo. To maintain blinding all children were provided with a daily ICS inhaler (active or placebo) and a rescue ICS inhaler (active or placebo). The daily ICS regimen consisted of 1 40?g actuation twice a day and the symptom-targeted regimen consisted of 1 40?g puff of ICS to accompany each puff of albuterol used for symptom relief. The combined group used both treatments. The primary outcome was TFE defined as an oral corticosteroid-requiring exacerbation and a secondary outcome was TF defined as >2 oral corticosteroid-requiring exacerbations. Statistical analysis compared the median TFE within a subgroup of each active treatment group versus the same placebo subgroup. Within each subgroup, proportional hazards regression was used to detect any significant differences compared to placebo. Resulting p-values were recalculated using the Hochberg adjustment for multiple comparisons. Clinical center, age group, and satisfaction of eligibility criterion were included as covariates. A separate but identical analysis compared the median time to TF among treatment groups and within subgroups.

Results: 843 children and adolescents were enrolled and 288 were randomized to combined (n=71), daily (n=72), rescue (n=71), and placebo (n=47) treatment. Tables 1 and 2 show the stratified results for TFE and TF, respectively. Some subgroups were more responsive to the ICS doses used including children who were younger, male, white, non-Hispanic, and who had allergic asthma.

Conclusions: In TREXA, certain demographic and baseline clinical characteristics were related to responsiveness to steroids. Research to validate these findings is warranted.

Funded by: National Heart, Lung, and Blood Institute and TEVA Pharmaceutical Industries, Ltd.

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Public release date: 22-May-2012
[ | E-mail | Share ]

Contact: Nathaniel Dunford
ndunford@thoracic.org
212-315-8620
American Thoracic Society

ATS 2012, SAN FRANCISCO A further analysis of a previously published National Heart, Lung, and Blood Institute (NHLBI) funded study of children with mild persistent asthma reports the relative benefits of inhaled corticosteroid (ICS) treatment varies among children with differing demographic and clinical characteristics.

"We performed post-hoc data analysis on 288 children enrolled in the TReating Children to Prevent Exacerbations of Asthma (TREXA) study performed by the NHLBI funded Childhood Asthma Research and Education (CARE) Network," said Lynn Gerald, PhD, MSPH, professor in the Department of Health Promotion Sciences and associate dean of research in the College of Public Health at the University of Arizona. "Our findings suggest that all children with mild persistent asthma benefit from ICS treatment, but some groups benefit more than others."

The TREXA trial compared four ICS treatment strategies: daily treatment (daily), daily treatment plus symptom-targeted treatment (combined), symptom-targeted only treatment (rescue), and placebo. Daily treatment, but not combined or rescue treatment, reduced the time to first exacerbation compared with placebo, and all three strategies reduced treatment failures. Time to treatment failure was defined as time to an oral corticosteroid-requiring exacerbation and treatment failure was defined as experiencing two or more oral corticosteroid-requiring exacerbations.

In post-hoc subgroup analyses using either time to first exacerbation or time to treatment failure as an outcome, children in the daily and combined groups who were younger (6-11 yrs versus 12-17 years), were non-Hispanic, had eczema, were skin test positive, and who had IgE levels >185K/uL experienced treatment benefit as compared to those assigned to placebo. Among children assigned to the rescue group, the results were similar to those above when using time to treatment failure as an outcome; however, when using time to first exacerbation as an outcome, only those with eczema, high IgE levels, and less than perfect asthma control during the run-in period were demonstrated to benefit when compared to placebo.

"Our study indicates that some groups of children with mild persistent asthma have greater exacerbation risk than others and therefore have more to gain from ICS treatment for reducing this risk," said Dr. Gerald. "These findings need to be validated in future studies."

###

"Predictors Of Response To Inhaled Corticosteroids: Stratified Results From The TREXA Trial" (Session C27, Tuesday, May 22, 2012: 8:15-10:45 a.m., Room 2010-2012, Moscone Center; Abstract 26378)

* Please note that numbers in this release may differ slightly from those in the abstract. Many of these investigations are ongoing; the release represents the most up-to-date data available at press time.

Abstract 26378
Predictors Of Response To Inhaled Corticosteroids: Stratified Results From The TREXA Trial
Type: Scientific Abstract
Category: 14.02 - Pediatric Asthma (PEDS)
Authors: L.B. Gerald1, J.K. Gerald1, N. Graber2, V. Chinchilli2, F.J. Martinez1; 1University of Arizona - Tucson, AZ/US, 2Penn State - Hershey, PA/US; TREXA Study Group

Abstract Body

Introduction: When taken daily, inhaled corticosteroids (ICSs) reduce exacerbations among children with mild persistent asthma. The TREXA trial compared 4 ICS treatment strategies: daily treatment (daily), daily treatment plus symptom-targeted treatment (combined), symptom-targeted only treatment (rescue), and placebo. Compared to placebo, daily treatment, but not combined or rescue treatment reduced the time to first exacerbation (TFE); however, all 3 strategies reduced treatment failures. Stratified analyses identifying subgroups most responsive to ICS treatment are presented here.

Methods: In this 44-week, randomized, double-blinded, placebo-controlled trial, children and adolescents 5? years of age with mild persistent asthma were enrolled from 5 clinical centers across the US. Participants were randomly assigned to 1 of 4 treatment groups: daily ICS plus symptom-targeted ICS (combined), daily ICS only (daily), symptom-targeted ICS only (rescue), and placebo. To maintain blinding all children were provided with a daily ICS inhaler (active or placebo) and a rescue ICS inhaler (active or placebo). The daily ICS regimen consisted of 1 40?g actuation twice a day and the symptom-targeted regimen consisted of 1 40?g puff of ICS to accompany each puff of albuterol used for symptom relief. The combined group used both treatments. The primary outcome was TFE defined as an oral corticosteroid-requiring exacerbation and a secondary outcome was TF defined as >2 oral corticosteroid-requiring exacerbations. Statistical analysis compared the median TFE within a subgroup of each active treatment group versus the same placebo subgroup. Within each subgroup, proportional hazards regression was used to detect any significant differences compared to placebo. Resulting p-values were recalculated using the Hochberg adjustment for multiple comparisons. Clinical center, age group, and satisfaction of eligibility criterion were included as covariates. A separate but identical analysis compared the median time to TF among treatment groups and within subgroups.

Results: 843 children and adolescents were enrolled and 288 were randomized to combined (n=71), daily (n=72), rescue (n=71), and placebo (n=47) treatment. Tables 1 and 2 show the stratified results for TFE and TF, respectively. Some subgroups were more responsive to the ICS doses used including children who were younger, male, white, non-Hispanic, and who had allergic asthma.

Conclusions: In TREXA, certain demographic and baseline clinical characteristics were related to responsiveness to steroids. Research to validate these findings is warranted.

Funded by: National Heart, Lung, and Blood Institute and TEVA Pharmaceutical Industries, Ltd.

---

[ | E-mail | Share ]

?

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

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