Efficacy of montelukast for treating perennial allergic rhinitis
Authors: Philip, George1; Williams-Herman, Debora1; Patel, Piyush2; Weinstein, Steven F.3; Alon, Achilles1; Gilles, Leen1; Tozzi, Carol A.1; Dass, S. Balachandra1; Reiss, Theodore F.1
Source: Allergy and Asthma Proceedings, Volume 28, Number 3, May-June 2007 , pp. 296-304(9)
Publisher: OceanSide Publications, Inc
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Abstract:
Perennial allergic rhinitis (PAR) is a chronic inflammatory nasal condition in individuals exposed year-round to allergens. This was a double-blind study of 15- to 85-year-old patients randomly allocated to montelukast, 10 mg (n = 630), placebo (n = 613), or the positive control cetirizine, 10 mg (n = 122) for 6 weeks. The primary efficacy end point was change from baseline in Daytime Nasal Symptoms Score (DNSS; mean of congestion, rhinorrhea, sneezing, and itching scores, rated daily by patients [scale: 0 = none to 3 = severe]) averaged during the initial 4 weeks (primary analysis) or entire 6 weeks of treatment. Also assessed were combined post hoc results of primary end point data from this study and another similarly designed study (Patel P, et al. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis, Ann Allergy Asthma Immunol 95:551, 2005). Over 4 weeks, montelukast showed numerical improvement over placebo in DNSS (least-squares mean difference of −0.04 [95% confidence interval {CI}, −0.09, 0.01]); the difference between cetirizine and placebo was significant: −0.10 (95% CI, −0.19, −0.01). However, when averaged over 6 weeks, neither active treatment was significantly different from placebo. The Rhinoconjunctivitis Quality-of-Life score was significantly improved by montelukast (p < 0.05), but not by cetirizine, during 4 and 6 weeks. The treatment effect of montelukast, but not cetirizine, generally remained consistent through the 6 weeks of treatment. In pooled data, montelukast consistently improved DNSS versus placebo during all 6 weeks of treatment (−0.07 [95% CI, −0.10, −0.04]). In conclusion, montelukast produced numerical improvement in daytime nasal symptoms and significant improvement in quality of life. In a pooled post hoc analysis, montelukast provided consistent improvement in daytime nasal symptoms over 6 weeks, supportive of an overall benefit in PAR.Keywords: Allergy; cetirizine; controlled clinical trial; leukotriene receptor antagonist; nasal symptoms; persistent allergic rhinitis; quality of life
Document Type: Research article
DOI: 10.2500/aap.2007.28.3000
Affiliations: 1: From the Merck Research Laboratories, Rahway, New Jersey, 2: Allied Research International, Mississauga, Ontario, Canada, and 3: Allergy & Asthma Specialists Medical Group and Research Center, Huntington Beach, California
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