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
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.
GlaxoSmithKline, Research Triangle Park, NC, USA.
Charlene M
CM
Prazma
University of Wisconsin-Madison, Madison, WI, USA.
James E
JE
Gern
Allergy and Asthma Specialists Medical Group, Huntington Beach, CA, USA.
Steven F
SF
Weinstein
GlaxoSmithKline, Research Triangle Park, NC, USA.
Barbara A
BA
Prillaman
GlaxoSmithKline, Research Triangle Park, NC, USA. Electronic address: david.a.stempel@gsk.com.
David A
DA
Stempel
D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy* / Q000821:virology*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D009093:Mucus / Q000821:virology; D010366:Peak Expiratory Flow Rate; D016133:Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000821:virology*; D012229:Rhinovirus / Q000302:isolation & purification; D012621:Seasons; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination
Asthma exacerbation; Fluticasone propionate; Fluticasone propionate/salmeterol combination; Human rhinovirus; Upper respiratory tract infection