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

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: http://dx.doi.org/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

Publication date: 2007-05-01

More about this publication?

• Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.
  
  The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.
  
  Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.
  
  The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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