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Clin Ther. 2018 Jul;40(7):1096-1107.e1. doi: 10.1016/j.clinthera.2018.04.021. Epub 2018 Jun 24.

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.

Author information

1
Subdivision of Allergy, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
2
Division of Allergy, Department of Internal Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
3
Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Republic of Korea.
4
Division of Allergy and Respiratory Medicine, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.
5
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
6
Division of Allergy and Clinical Immunology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Republic of Korea.
7
Pulmonary-Allergy Division, Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Republic of Korea.
8
Department of Internal Medicine, College of Medicine, Dong-A University, Busan, Republic of Korea.
9
Department of Internal Medicine, Kosin University College of Medicine, Busan, Republic of Korea.
10
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
11
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
12
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.
13
Division of Respirology and Allergy, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
14
Division of Allergy, Department of Medicine, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea.
15
Division of Allergy and Clinical Immunology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
16
Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University College of Medicine, Busan, Republic of Korea.
17
Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
18
Division of Allergy and Clinical Immunology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
19
Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.
20
Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
21
Hanmi Pharmaceutical Co, Seoul, Republic of Korea.
22
Division of Allergy and Respiratory Medicine, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea. Electronic address: schalr@schmc.ac.kr.

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.

IMPLICATIONS:

The fixed-dose combination of montelukast and levocetirizine was effective and safe in treating perennial allergic rhinitis in patients with asthma compared with montelukast alone. ClinicalTrials.gov identifier: NCT02552667.

KEYWORDS:

allergic rhinitis; asthma; clinical trial; fixed-dose combination; levocetirizine; montelukast

PMID:
29945738
DOI:
10.1016/j.clinthera.2018.04.021
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