Authors: Day, James H.; Briscoe, Maureen P.; Ratz, Jodan D.; Ellis, Anne K.; Yao, Ruji; Danzig, Melvyn

Source: Allergy and Asthma Proceedings, Volume 30, Number 3, May-June 2009 , pp. 270-276(7)

Publisher: OceanSide Publications, Inc

Abstract:

Onset of action is recognized as an important pharmacologic property of allergic rhinitis (AR) medications. This study was designed to evaluate the onset of action of loratadine/montelukast (L/M; 10 mg/10 mg) versus placebo in subjects with ragweed-induced seasonal AR (SAR). A single-center, double-blind, parallel-group study of ragweed-sensitive AR subjects (n = 310) was performed in the Environmental Exposure Unit (EEU). Subjects were exposed to ragweed pollen in the EEU and symptoms were recorded at 30, 60, 90, and 120 minutes before a single dose of L/M or placebo. After dosing, symptoms were recorded for 4 hours, at 15-minute intervals for the first 2 hours and at 30-minute intervals for the final 2 hours. The primary end point was time to onset of action of L/M, defined as the first time point at which the mean change from baseline in total symptom score (TSS) for L/M became and remained significantly better than placebo. Secondary end points included nasal congestion scores and peak nasal inspiratory flow (PNIF). The onset of action of L/M for TSS was 1 hour and 15 minutes (p = 0.005 versus placebo). L/M reduced nasal congestion as indicated by significant improvements in both the nasal congestion score (p = 0.011) and the PNIF measurements (p = 0.007) within 1 hour and 15 minutes postdose. The incidence of treatment-emergent adverse events was similar between groups. The onset of action after treatment with L/M was 1 hour and 15 minutes for TSS, as well as nasal congestion. L/M was well tolerated.

Keywords: Allergen challenge; allergic rhinitis; antihistamine; antileukotriene; Environmental Exposure Unit; loratadine/montelukast; nasal congestion; onset of action; peak nasal inspiratory flow; total symptom score

Document Type: Research article

DOI: http://dx.doi.org/10.2500/aap.2009.30.3234

Affiliations: 1: Department of Medicine, Queen's University and Division of Allergy and Immunology, Kingston General Hospital, Kingston, Ontario, Canada. dayj@kgh.kari.net

Publication date: 2009-05-01

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.
• Editorial Board
• Information for Authors
• Submit a Paper
• Information for Advertisers
• Reprint Requests
• ingentaconnect is not responsible for the content or availability of external websites

Related content

• In this: publication
• By this: publisher
• In this Subject: Allergy & Immunology
• By this author: Day, James H. ;  Briscoe, Maureen P. ;  Ratz, Jodan D. ;  Ellis, Anne K. ;  Yao, Ruji ;  Danzig, Melvyn

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers