Dataset Information

The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study.

ABSTRACT:

Background

A seasonal peak in asthma exacerbations in the fall has previously been reported. The association between fall exacerbations and viral respiratory tract infections (RTI) remains uncertain.

Objective

To investigate the number of fall exacerbations and the incidence of RTIs in a pediatric asthmatic population using an at-home mucus collection methodology.

Methods

This was a 16-week, multicenter, randomized, double-blind, parallel-group exploratory study. Children, 4-11 years of age with a clinical diagnosis of asthma requiring use of an inhaled corticosteroid, a morning peak expiratory flow ?70% predicted and a history of ?1 asthma exacerbation during the previous respiratory viral season were eligible for enrollment. Subjects were randomized (1:1) to receive fluticasone propionate/salmeterol (FP/SAL) 100/50 mcg or FP 100 mcg prior to starting school. Subjects collected mucus samples using an at-home kit when they experienced respiratory symptoms. Mucus samples obtained during symptomatic periods were analyzed for common respiratory viruses by multiplex polymerase chain reaction. The number of exacerbations requiring systemic corticosteroids was recorded.

Results

In total, 339 (FP/SAL, n = 171; FP, n = 168) subjects were randomized and included in the intent-to-treat population; 292 (86%) completed the study. Of the 537 mucus samples collected, 64% tested positive for viruses, but only 6% of positive samples were associated with an asthma exacerbation. Exacerbations were infrequent, with only 41 subjects reporting 49 exacerbations in total. Adverse events were reported in 66% of subjects.

Conclusions

In a susceptible population, the fall asthma exacerbation rates in children were low despite frequent detection of viral RTIs. NCT01192178; GSK ID: ADA113872.

SUBMITTER: Prazma CM

PROVIDER: S-EPMC7125883 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Publications

The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study.

Prazma Charlene M CM Gern James E JE Weinstein Steven F SF Prillaman Barbara A BA Stempel David A DA

Respiratory medicine 20150624 10

<h4>Background</h4>A seasonal peak in asthma exacerbations in the fall has previously been reported. The association between fall exacerbations and viral respiratory tract infections (RTI) remains uncertain.<h4>Objective</h4>To investigate the number of fall exacerbations and the incidence of RTIs in a pediatric asthmatic population using an at-home mucus collection methodology.<h4>Methods</h4>This was a 16-week, multicenter, randomized, double-blind, parallel-group exploratory study. Children, ...[more]

PMID: 26289742

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Project description:BackgroundRoflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein.MethodsIn this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures.ResultsAcross 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016.ConclusionThis study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment.

Dataset Information

The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study.

Background

Objective

Methods

Results

Conclusions

Publications

The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study.

Similar Datasets

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