A placebo-controlled, dose-ranging study of montelukast, a cysteinyl leukotriene–receptor antagonist☆,☆☆,★,★★,♢
Section snippets
Patients
Healthy, nonsmoking (for longer than 1 year) patients with chronic asthma (men and women of nonchildbearing potential) 18 to 65 years of age were enrolled in the study. Eligible patients were required to demonstrate an FEV1 between 40% and 80% of the predicted value (withholding short-acting, inhaled β2-adrenergic agonist for 6 hours) and reversible airways obstruction (an increase in FEV1 absolute value of 15% or greater) 20 to 30 minutes after inhalation of β–agonist at least twice each
Patients
Three hundred forty-three patients (285 receiving montelukast and 58 receiving placebo) entered the active, double-blind treatment period. Of these, 307 (90%) completed active treatment and 299 (87%) completed the placebo washout period. In general, discontinuations were more frequent in the placebo group (11 [19%]) than in the pooled montelukast group (33 [12%]). There were no clinically meaningful differences between the treatment groups in demographic parameters or baseline characteristics (
DISCUSSION
Montelukast improved asthma control over a 6-week treatment period; however, a relationship between daily dose of montelukast (10 to 200 mg), dosing interval (once daily versus twice daily), and clinical efficacy parameters was not observed in this study. The similarity of response between once daily and twice daily administration and the persistent effect throughout the once daily dosing regimen demonstrated that twice daily dosing provided no additional benefit to that of once daily
Acknowledgements
We thank the members of the Montelukast Asthma Study Group: Donald Aaronson, MD; Leonard C. Altman, MD; David Appel, MD; Kathryn Blake, PharmD; Milan L Brandon, MD; Edwin Bronsky, MD; William Busse, MD; Paul Chervinsky, MD; Robert J. Dockhorn, MD; John Georgitis, MD; Thomas B. Edwards, MD; Leslie Hendeles, PharmD; Philip E. Korenblat, MD; F. Gilbert McMahon, MD; Zev B. Munk, MD; John Murray, MD; Michael J. Noonan, MD; Jacob L. Pinnas, MD; Bruce Prenner, MD; Allen Segal, MD; James Seltzer, MD;
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Cited by (0)
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From athe University of Washington, Seattle; bBreco Research, Houston; cThe Clinical Research Institute, San Diego; and dMerck Research Laboratories, Rahway.
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Supported by a grant from Merck Research Laboratories
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The members of the Montelukast Asthma Study Group are listed in the acknowledgments.
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Reprint requests: Theodore F. Reiss, MD, Merck Research Laboratories, PO Box 2000, RY 33-648, Rahway, NJ 07065.
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