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. Issue 10 (October 2015)

• Record Type: Journal Article
• Authors: Prazma, Charlene M.; Gern, James E.; Weinstein, Steven F.; Prillaman, Barbara A.; Stempel, David A.
• Is Part Of: Respiratory medicine. Volume 109:Issue 10(2015)
• Page Start: 1280
• Page End: 1286
• Publication Date: 2015-10
• Subjects: Fluticasone propionate/salmeterol combination -- Fluticasone propionate -- Asthma exacerbation -- Human rhinovirus -- Upper respiratory tract infection; AE adverse event -- C-ACT Childhood Asthma Control Test -- ER emergency room -- FP/SAL fluticasone propionate/salmeterol combination -- FP fluticasone propionate -- HRV human rhinovirus -- ICS inhaled corticosteroids -- ITT intent-to-treat -- PEF peak expiratory flow -- RT-PCR real-time polymerase chain reaction -- RSV Respiratory Syncytial Virus -- RTI respiratory tract infection -- SAE serious adverse event -- SCS systemic corticosteroids; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2015.06.010
• Languages: English
• ISSNs: 0954-6111

Abstract

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. Highlights: Upper respiratory viral infections determined by at-home mucus collection at the time of symptoms. The majority of subjects reported ≥1 period of upper respiratory symptoms. Asthma exacerbations were infrequent, despite treatment and it being the fall season. The majority of upper respiratory viral infections were not associated with exacerbations. Additional virus, environment or host factors may influence exacerbation risk.