Effect of fluticasone/salmeterol administered via a single device on exercise-induced bronchospasm in patients with persistent asthma.
BACKGROUND
Exercise is a common trigger of asthma symptoms in patients with persistent asthma.


OBJECTIVE
To evaluate the protective effect of fluticasone/salmeterol against exercise-induced bronchospasm.


METHODS
Multicenter, randomized, double-blind, parallel-group trial of 192 asthma patients who used moderate-dose inhaled corticosteroids. Patients (aged 12-50 years; mean forced expiratory volume in 1 second [FEV1], 78% of predicted at baseline) were randomized to receive fluticasone/salmeterol (250/50 microg twice daily) or fluticasone alone (250 microg twice daily) via Diskus for 4 weeks. Exercise challenge tests were performed 1 and 8.5 hours after administration of the first (day 1) and last (week 4) doses of blinded study medication.


RESULTS
On day 1 and at week 4, mean +/- SEM values for the maximal percentage decline in FEV1 1 hour after drug administration were 11.4% +/- 1.5% and 10.9% +/- 1.5% for fluticasone/salmeterol compared with 20.0% +/- 1.7% and 18.4% +/- 1.8% for fluticasone (P < .001). At 8.5 hours, mean +/- SEM values on day 1 and at week 4 were 11.6% +/- 1.4% and 8.9% +/1.1%, respectively, for fluticasone/salmeterol and 12.6% +/- 1.6% and 12.9% +/- 1.4%, respectively, for fluticasone (P = .01 at week 4). More fluticasone-treated patients did not complete the 8.5-hour exercise challenges (36% on day 1 and 33% at week 4) compared with the fluticasone/salmeterol group (18% each) (P < or = .01). Improvements in peak expiratory flow rate and albuterol rescue-free days were significantly greater with fluticasone/salmeterol vs fluticasone over weeks 1 to 4 (P < or = .03).


CONCLUSIONS
Consistent with the improvements in other measures of asthma control, long-term fluticasone/salmeterol therapy also provided protection against exercise-induced bronchospasm in patients with persistent asthma.
Weiler
John M
JM
University of Iowa, Iowa City, USA. jweiler@compleware.com
Nathan
Robert A
RA
Rupp
Ned T
NT
Kalberg
Christopher J
CJ
Emmett
Amanda
A
Dorinsky
Paul M
PM
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage* / Q000494:pharmacology* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001250:Asthma, Exercise-Induced / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D005080:Exercise Test; D005260:Female; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000068298:Fluticasone; D000420:Albuterol