Original articles: Asthma, rhinitis, other respiratory diseasesConcomitant montelukast and loratadine as treatment for seasonal allergic rhinitis: A randomized, placebo-controlled clinical trial☆,☆☆
Section snippets
Study design
This multicenter (N = 12), randomized, placebo-controlled, parallel-group (5 treatment groups) trial with a 1-week, single-blind, placebo run-in period and a 2-week, double-blind treatment period was conducted between March and May of 1997 in California (San Diego, Orange County, Sacramento, and San Jose–Sunnyvale). The study design included 5 visits, separated by 5 to 10 days. Visit 1 was the prestudy visit and the placebo run-in period started at visit 2. Patients were randomly allocated at
Patients
Of 834 screened patients, 460 patients were randomly allocated to 1 of 5 treatment groups. Absence of reactivity to 1 or more allergens was the most common reason for excluding patients from randomization. Patient baseline characteristics (Table I) were similar across treatment groups.
Empty Cell Treatment groups Placebo MNT 10 mg MNT 20 mg LRT 10 mg MNT 10 mg + LRT 10 mg No. patients 91 95 90 92 90 No. men (%) 45 (49.5) 40 (42.1) 33 (36.7) 43 (46.7) 44 (48.9) Median age, y
Discussion
This is the first clinical trial to demonstrate that a cysteinyl leukotriene receptor antagonist and an H1-receptor antagonist taken concomitantly provide at least additive efficacy in the treatment of seasonal allergic rhinitis and associated allergic eye symptoms. The trial evaluated the effects of montelukast, a cysteinyl leukotriene receptor antagonist; loratadine, an H1-receptor antagonist; and the 2 agents taken concomitantly in patients with seasonal allergic rhinitis. Montelukast 10 mg
Acknowledgements
We thank Liz Hillyer for editorial assistance; Carmen Ayala and Jill Balcavage for study monitoring; Alan Nies, MD, and Beth C. Seidenberg, MD, for discussions; and Reynold Spector, MD, for his scientific guidance.
The Montelukast Study Group for this protocol consisted of the following investigators: William E. Berger, MD, Mission Viejo, Calif; Milan Brandon, MD, San Diego, Calif; Bradley E. Chipps, MD, Sacramento, Calif; Stanley P. Galant, MD, Orange, Calif; Eli O. Meltzer, MD, San Diego,
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Supported by a grant from Merck Research Laboratories.
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Reprint requests: Kerstin Malmstrom, PhD, Merck Research Laboratories, RY 32-621, PO Box 2000, Rahway, NJ 07065.