Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring.
Abstract | BACKGROUND: OBJECTIVE: METHODS: After a 3- to 5-day, single-blind placebo run-in period, 1302 male and female patients (aged 15-81 years) with active allergic rhinitis symptoms were randomly assigned to receive montelukast 10 mg (n = 348), loratadine 10 mg (n = 602), or placebo (n = 352) administered once daily at bedtime for 2 weeks during the spring allergy season. RESULTS: Mean patient characteristics and symptom scores at baseline were similar for the three treatment groups. The primary end-point, daytime nasal symptoms score (mean of nasal congestion, rhinorrhea, nasal pruritus, and sneezing scores; 0-3 scale), improved from baseline during treatment by (least squares mean, 95% confidence interval) - 0.37 (- 0.43, - 0.31), - 0.47 (- 0.52, - 0.43), and - 0.24 (- 0.29, - 0.18) in the montelukast, loratadine, and placebo groups, respectively (P < or = 0.001 comparing each active treatment with placebo). Mean changes from baseline in all other diary-based scores, including night-time and eye symptom scores, were significantly greater for each active treatment than for placebo. The rhinoconjunctivitis quality of life overall score improved significantly with montelukast and with loratadine as compared with placebo. Montelukast and loratadine showed a safety profile comparable to that of placebo. CONCLUSION:
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Authors | G Philip, K Malmstrom, F C Hampel, S F Weinstein, C F LaForce, P H Ratner, M-P Malice, T F Reiss, Montelukast Spring Rhinitis Study Group |
Journal | Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology
(Clin Exp Allergy)
Vol. 32
Issue 7
Pg. 1020-8
(Jul 2002)
ISSN: 0954-7894 [Print] England |
PMID | 12100048
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Acetates
- Cyclopropanes
- Leukotriene Antagonists
- Quinolines
- Sulfides
- montelukast
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Topics |
- Acetates
(adverse effects, therapeutic use)
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Cyclopropanes
- Double-Blind Method
- Eosinophils
(physiology)
- Female
- Humans
- Leukotriene Antagonists
(therapeutic use)
- Male
- Middle Aged
- Quinolines
(adverse effects, therapeutic use)
- Rhinitis, Allergic, Seasonal
(blood, drug therapy)
- Sulfides
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