Original articles: Asthma, rhinitis, other respiratory diseases
Concomitant montelukast and loratadine as treatment for seasonal allergic rhinitis: A randomized, placebo-controlled clinical trial,☆☆

https://doi.org/10.1067/mai.2000.106040Get rights and content

Abstract

Background: Nasal challenge studies have suggested histamine and cysteinyl leukotrienes are important proinflammatory mediators in allergic rhinitis. This study was designed to determine the efficacy of montelukast, a cysteinyl leukotriene receptor antagonist, administered alone or concomitantly with loratadine, an H1-receptor antagonist, in seasonal allergic rhinitis. Objective: The purpose of this study was to determine the effect of concomitant use of montelukast and loratadine in the treatment of seasonal allergic rhinitis. Methods: In this multicenter (N = 12) double-blind, randomized, parallel-group, placebo-controlled 2-week trial, 460 men and women, aged 15 to 75 years, with spring seasonal allergic rhinitis were randomly allocated to receive 1 of the following 5 treatments: montelukast 10 or 20 mg, loratadine 10 mg, montelukast 10 mg with loratadine 10 mg, or placebo, once daily in the evening. The primary end point was daytime nasal symptoms score (average of congestion, rhinorrhea, itching, and sneezing). Other end points were eye symptoms, nighttime symptoms, individual daytime nasal symptoms, global evaluations (patient’s and physician’s), and rhinoconjunctivitis quality-of-life scores. Results: Concomitant montelukast with loratadine improved the primary end point significantly (P < .001) compared with placebo and each agent alone. Compared with placebo, montelukast with loratadine also significantly improved eye symptoms, nighttime symptoms, individual daytime nasal symptoms, global evaluations, and quality of life. Montelukast alone and loratadine alone caused modest improvements in rhinitis end points. All treatments were similarly well tolerated. Conclusions: Concomitant montelukast with loratadine provided effective treatment for seasonal allergic rhinitis and associated eye symptoms with a safety profile comparable with placebo. (J Allergy Clin Immunol 2000;105:917-22.)

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.

. Patient baseline characteristics (mean ± SD)

Empty CellTreatment groups
PlaceboMNT 10 mgMNT 20 mgLRT 10 mgMNT 10 mg + LRT 10 mg
No. patients9195909290
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.

    ☆☆

    Reprint requests: Kerstin Malmstrom, PhD, Merck Research Laboratories, RY 32-621, PO Box 2000, Rahway, NJ 07065.

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