Supported by a grant from Merck Research Laboratories, Rahway, New Jersey, USA.
Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring
Article first published online: 5 JUL 2002
Clinical & Experimental Allergy
Volume 32, Issue 7, pages 1020–1028, July 2002
How to Cite
Philip, G., Malmstrom, K., Hampel, F. C., Weinstein, S. F., LaForce, C. F., Ratner, P. H., Malice, M.-P., Reiss, T. F. and for the Montelukast Spring Rhinitis Study Group (2002), Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clinical & Experimental Allergy, 32: 1020–1028. doi: 10.1046/j.1365-2222.2002.01422.x
- Issue published online: 5 JUL 2002
- Article first published online: 5 JUL 2002
- Submitted 30 July 2001; revised 14 January 2002; accepted 15 February 2002
Vol. 39, Issue 10, 1622, Article first published online: 10 SEP 2009
- cysteinyl leukotriene type-1 receptor antagonist;
- H1-receptor antagonist;
- quality of life;
- seasonal allergic rhinitis
Background Cysteinyl leukotrienes are important proinflammatory mediators believed to have a role in allergic rhinitis.
Objective This multicentre, randomized, double-blind, placebo- and active-controlled trial evaluated the effectiveness and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, for treating patients with seasonal allergic rhinitis.
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 ≤ 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 Montelukast is well tolerated and provides improvements in daytime and night-time symptoms, as well as quality of life parameters, for patients with seasonal allergic rhinitis.