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A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis

Title
A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis
Authors
Kim, Mi-KyeongLee, Sook YoungPark, Hae-SimYoon, Ho JooKim, Sang-HaCho, Young JooYoo, Kwang-HaLee, Soo-KeolKim, Hee-KyooPark, Jung-WonPark, Heung-WooChung, Jin-HongChoi, Byoung WhuiLee, Byung-JaeChang, Yoon-SeokJo, Eun-JungLee, Sang-YeubCho, You SookJee, Young-KooLee, Jong-MyungJung, JinaPark, Choon-Sik
Ewha Authors
조영주
SCOPUS Author ID
조영주scopus
Issue Date
2018
Journal Title
CLINICAL THERAPEUTICS
ISSN
0149-2918JCR Link

1879-114XJCR Link
Citation
CLINICAL THERAPEUTICS vol. 40, no. 7, pp. 1096 - 1107
Keywords
allergic rhinitisasthmaclinical trialfixed-dose combinationlevocetirizinemontelukast
Publisher
ELSEVIER
Indexed
SCIE; SCOPUS WOS scopus
Document Type
Article
Abstract
Purpose: The aim of this study was to evaluate the efficacy and safety of a fixed-dose combination of montelukast and levocetirizine in patients with perennial allergic rhinitis with mild to moderate asthma compared with the efficacy and safety of montelukast alone. Methods: This study was a 4-week, randomized, multicenter, double-blind, Phase III trial. After a 1 week placebo run-in period, the subjects were randomized to receive montelukast (10 mg/day, n = 112) or montelukast (10 mg/day)/levocetirizine (5 mg/day) (n = 116) treatment for 4 weeks. The primary efficacy end point was mean daytime nasal symptom score. Other efficacy end points included mean nighttime nasal symptom score, mean composite symptom score, overall assessment of allergic rhinitis by both subjects and physicians, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, asthma control test score, and the frequency of rescue medication used during the treatment period. Findings: Of 333 patients screened for this study, 228 eligible patients were randomized to treatment. The mean (SD) age of patients was 43.32 (15.02) years, and two thirds of subjects were female (66.67%). The demographic characteristics were similar between the treatment groups. Compared with the montelukast group, the montelukast/levocetirizine group reported significant reductions in mean daytime nasal symptom score (least squares mean [SE] of combination vs montelukast, -0.98 [0.06] vs -0.81 [0.06]; P = 0.045). For all other allergic rhinitis efficacy end points, the montelukast/levocetirizine group showed greater improvement than the montelukast group. Similar results were observed in overall assessment scores and in FEV1, FVC, FEV1/FVC, and asthma control test score changes from baseline for the 2 treatment groups. Montelukast/levocetirizine was well tolerated, and the safety profile was similar to that observed in the montelukast group. (C) 2018 The Authors. Published by Elsevier Inc.
DOI
10.1016/j.clinthera.2018.04.021
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의과대학 > 의학과 > Journal papers
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