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
- 주제(키워드) allergic rhinitis , asthma , clinical trial , fixed-dose combination , levocetirizine , montelukast
- 주제(기타) Pharmacology & Pharmacy
- 설명문(일반) [Kim, Mi-Kyeong] Chungbuk Natl Univ, Coll Med, Dept Internal Med, Subdivis Allergy, Cheongju, South Korea; [Lee, Sook Young] Catholic Univ Korea, Dept Internal Med, Div Allergy, Seoul, South Korea; [Park, Hae-Sim] Ajou Univ, Sch Med, Dept Allergy & Clin Immunol, Suwon, South Korea; [Yoon, Ho Joo] Hanyang Univ, Coll Med, Dept Internal Med, Div Allergy & Resp Med, Seoul, South Korea; [Kim, Sang-Ha] Yonsei Univ, Wonju Coll Med, Dept Internal Med, Wonju, South Korea; [Cho, Young Joo] Ewha Womans Univ, Coll Med, Dept Internal Med, Div Allergy & Clin Immunol, Seoul, South Korea; [Yoo, Kwang-Ha] Konkuk Univ, Coll Med, Dept Internal Med, Pulmonary Allergy Div, Seoul, South Korea; [Lee, Soo-Keol] Dong A Univ, Coll Med, Dept Internal Med, Busan, South Korea; [Lee, Soo-Keol] Kosin Univ, Coll Med, Dept Internal Med, Busan, South Korea; [Park, Jung-Won] Yonsei Univ, Coll Med, Dept Internal Med, Seoul, South Korea; [Park, Heung-Woo] Seoul Natl Univ, Coll Med, Dept Internal Med, Seoul, South Korea; [Chung, Jin-Hong] Yeungnam Univ, Coll Med, Dept Internal Med, Daegu, South Korea; [Choi, Byoung Whui] Chung Ang Univ, Coll Med, Dept Internal Med, Div Respirol & Allergy, Seoul, South Korea; [Lee, Byung-Jae] Sungkyunkwan Univ, Coll Med, Samsung Med Ctr, Dept Med,Div Allergy, Seoul, South Korea; [Chang, Yoon-Seok] Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Div Allergy & Clin Immunol, Seongnam, South Korea; [Jo, Eun-Jung] Pusan Natl Univ, Coll Med, Dept Internal Med, Div Pulmonol Allergy & Crit Care Med, Busan, South Korea; [Lee, Sang-Yeub] Korea Univ, Coll Med, Dept Internal Med, Div Pulmonol Allergy & Crit Care Med, Seoul, South Korea; [Cho, You Sook] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Internal Med,Div Allergy & Clin Immunol, Seoul, South Korea; [Jee, Young-Koo] Dankook Univ, Coll Med, Dept Internal Med, Cheonan, South Korea; [Lee, Jong-Myung] Kyungpook Natl Univ, Sch Med, Dept Internal Med, Daegu, South Korea; [Jung, Jina] Hanmi Pharmaceut Co, Seoul, South Korea; [Park, Choon-Sik] Soonchunhyang Univ, Bucheon Hosp, Dept Internal Med, Div Allergy & Resp Med, 170 Jomaru Ro, Bucheon, Gyenggi Do, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 ELSEVIER
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000155748
- 본문언어 영어
- Published As http://dx.doi.org/10.1016/j.clinthera.2018.04.021
초록/요약
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.
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