Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. [Ann Allergy Asthma Immunol] Journal article | | Title | Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. | | Author(s) | van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF, Montelukast Spring Rhinitis Investigator Group | | Institution | Merck & Co. Inc. Rahway, New Jersey, USA. janet_vanadelsberg@merck.com | | Source | Ann Allergy Asthma Immunol 2003 Feb; 90(2):214-22. | | MeSH | Acetates
Adolescent
Adult
Aged
Aged, 80 and over
Double-Blind Method
Female
Humans
Leukotriene Antagonists
Male
Middle Aged
Quality of Life
Quinolines
Research Support, Non-U.S. Gov't
Rhinitis, Allergic, Seasonal
Severity of Illness Index
Treatment Outcome
| | Abstract | BACKGROUND: Symptoms of allergic rhinitis are mediated in part by cysteinyl leukotrienes.
OBJECTIVE: To evaluate the clinical benefit of montelukast, a cysteinyl leukotriene receptor antagonist, administered once daily for treating seasonal allergic rhinitis.
METHODS: This multicenter, randomized, double-blind, placebo- and active-controlled study enrolled 1,214 healthy, nonsmoking outpatients aged 15 to 85 years with spring allergic rhinitis, positive skin test to a spring allergen, and predefined daytime nasal symptoms. After a 3- to 5-day placebo run-in period, patients were randomly assigned to treatment with montelukast 10 mg (n = 522), loratadine 10 mg (n = 171), or placebo (n = 521) once daily at bedtime for 2 weeks. During the run-in and treatment periods, symptoms were evaluated in a daily diary using a 0 (best) to 3 (worst) scale.
RESULTS: Baseline characteristics of randomized patients were clinically similar in the three treatment groups. Montelukast was significantly more effective than placebo (P = 0.003) in improving the daytime nasal symptoms score (difference in least square means, -0.09; 95% confidence interval, -0.16, -0.03) averaged over 2 weeks of therapy. The treatment effect of montelukast was significantly greater (P < 0.05), relative to placebo, for all secondary endpoints, including nighttime symptoms and daytime eye symptoms, patient and physician global evaluations of allergic rhinitis, and rhinoconjunctivitis quality of life. Loratadine, which served as a positive control, was significantly more effective than placebo for most endpoints, validating the study results. Both montelukast and loratadine were well tolerated.
CONCLUSION: Therapy with montelukast significantly improves assessments of symptom severity as well as quality-of-life parameters for patients with seasonal allergic rhinitis. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 12602669 |
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