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

Charlene M Prazma, James E Gern, Steven F Weinstein, Barbara A Prillaman, David A Stempel, Charlene M Prazma, James E Gern, Steven F Weinstein, Barbara A Prillaman, David A Stempel

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.

Keywords: Asthma exacerbation; Fluticasone propionate; Fluticasone propionate/salmeterol combination; Human rhinovirus; Upper respiratory tract infection.

Copyright © 2015 Elsevier Ltd. All rights reserved.

Figures

Fig. 1
Fig. 1
Summary of subject disposition and flow (ITT population).
Fig. 2
Fig. 2
Summary of mucus sample characterization (ITT population): Mucus samples were collected as described in methods and analyzed by PCR for virus content. The cumulative total number of samples collected depicted by the number collected per treatment group and further characterized by the number of virus positive samples and HRV positive samples collected per treatment group. HRV, human rhinovirus; ITT, intent-to-treat.
Fig. 3
Fig. 3
Summary of the number of exacerbations (ITT population): Exacerbations characterized by the number with or without a mucus sample collected within the 5 days prior or 2 days following the exacerbation. The exacerbations with a mucus sample were characterized as virus-positive and virus-negative exacerbations. Of the virus-positive exacerbations the number associated with HRV infection is shown. HRV, human rhinovirus; ITT, intent-to-treat.
Fig. 4
Fig. 4
Summary of the mean change in daily asthma symptoms and rescue medication use (ITT population): A) Change from day −7 in mean daily asthma symptom score and 7 days prior and 7 days following exacerbation. B) Change from day −7 in mean daily rescue medication use in the 7 days prior and 7 days following exacerbation. Mean values were determined for subjects in each treatment group on each day for a 2-week period surrounding the exacerbation. The first day of exacerbation treatment with ICS was determined as Day 0. FP, fluticasone propionate; FP/SAL, fluticasone propionate/salmeterol; ITT, intent-to-treat.

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Source: PubMed

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