Effects of montelukast (MK-0476); a potent cysteinyl leukotriene receptor antagonist, on bronchodilation in asthmatic subjects treated with and without inhaled corticosteroids.
BACKGROUND
Cysteinyl leukotriene release in association with airway inflammation is a feature of clinical asthma. The acute effects of montelukast (MK-0476), a potent, orally administered, specific cysteinyl leukotriene receptor antagonist, on airways obstruction was assessed in patients with mild to moderately severe asthma.


METHODS
Twenty two asthmatic subjects were randomised to receive montelukast, 100 mg or 250 mg, or placebo in a double blind, three period, crossover trial. Ten of the patients were using concomitant inhaled corticosteroids.


RESULTS
Montelukast increased the forced expiratory volume in one second (FEV1) from predose baseline values compared with placebo, the percentage point differences between montelukast and placebo being 8.6% (95% CI 3.6 to 13.6) and 8.5% (95% CI 3.5 to 13.5) for the 100 mg and 250 mg doses, respectively.


CONCLUSIONS
Single oral doses of montelukast 100 mg and 250 mg produced significant increases in FEV1 irrespective of the concurrent use of inhaled corticosteroids in asthmatic subjects with airflow limitation.
Reiss
T F
TF
Department of Pulmonary Immunology, Merck Research Laboratories, Rahway, New Jersey 07065, USA.
Sorkness
C A
CA
Stricker
W
W
Botto
A
A
Busse
W W
WW
Kundu
S
S
Zhang
J
J
D000085:Acetates / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000627:therapeutic use*; D000704:Analysis of Variance; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D018102:Receptors, Leukotriene B4 / Q000037:antagonists & inhibitors*; D013440:Sulfides
D000085:Acetates; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D018102:Receptors, Leukotriene B4; D013440:Sulfides; C093875:montelukast; D000420:Albuterol