Protection against exercise-induced bronchoconstriction two hours after a single oral dose of montelukast.
The objective of this double-blind cross-over study was to evaluate montelukast for the prevention of exercise-induced bronchoconstriction (EIB). Sixty-two patients with EIB (post-exercise decrease in forced expiratory volume in 1 second (FEV(1)) > or = 20% at pre-randomization) were randomized to montelukast 10 mg or placebo, followed by exercise-challenge 2, 12, and 24 hours postdose. The primary endpoint was the maximum percent-fall in FEV(1) (from pre-exercise FEV(1)) during 60 minutes after exercise-challenge at 2 hours postdose. This endpoint was improved after montelukast (mean +/- SD = 11.7% +/- 10.8) versus placebo (17.5% +/- 13.8) (p < or = 0.001); numerically greater improvements were seen at 12 hours and 24 hours. A quicker time to recovery after challenge (p < or = 0.001) and a smaller area under the curve for percent-fall in FEV(1) during 60 minutes after challenge (p < or = 0.01) were seen with montelukast at 2 hours. At this timepoint, more patients taking montelukast (45/54) than taking placebo (37/54) were protected against EIB (p = 0.039). We concluded that montelukast provided significant protection against EIB at 2 hours after a single dose.
Philip
George
G
Merck Research Laboratories. Rahway, NJ 07065, USA. george.philip@merck.com
Villarán
Cesar
C
Pearlman
David S
DS
Loeys
Tom
T
Dass
S Balachandra
SB
Reiss
Theodore F
TF
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001250:Asthma, Exercise-Induced / Q000188:drug therapy* / Q000503:physiopathology*; D016084:Bronchoconstriction / Q000187:drug effects*; D018592:Cross-Over Studies; D003521:Cyclopropanes; D015444:Exercise; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D013440:Sulfides; D013997:Time Factors
D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast