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

Mi Kyeong Kim, Sook Young Lee, Hae Sim Park, Ho Joo Yoon, Sang Ha Kim, Young Joo Cho, Kwang Ha Yoo, Soo Keol Lee, Hee Kyoo Kim, Jung Won Park, Heung Woo Park, Jin Hong Chung, Byoung Whui Choi, Byung Jae Lee, Yoon Seok Chang, Eun Jung Jo, Sang Yeub Lee, You Sook Cho, Young Koo Jee, Jong Myung Lee & 2 others Jina Jung, Choon Sik Park

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1096-1107.e1
JournalClinical Therapeutics
Volume40
Issue number7
DOIs
Publication statusPublished - 2018 Jul 1

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montelukast
Asthma
Safety
Vital Capacity
Forced Expiratory Volume
Therapeutics
Rhinitis, Allergic, Perennial
Nose
levocetirizine
Allergic Rhinitis

Keywords

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

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

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. / Kim, Mi Kyeong; Lee, Sook Young; Park, Hae Sim; Yoon, Ho Joo; Kim, Sang Ha; Cho, Young Joo; Yoo, Kwang Ha; Lee, Soo Keol; Kim, Hee Kyoo; Park, Jung Won; Park, Heung Woo; Chung, Jin Hong; Choi, Byoung Whui; Lee, Byung Jae; Chang, Yoon Seok; Jo, Eun Jung; Lee, Sang Yeub; Cho, You Sook; Jee, Young Koo; Lee, Jong Myung; Jung, Jina; Park, Choon Sik.

In: Clinical Therapeutics, Vol. 40, No. 7, 01.07.2018, p. 1096-1107.e1.

Research output: Contribution to journalArticle

Kim, MK, Lee, SY, Park, HS, Yoon, HJ, Kim, SH, Cho, YJ, Yoo, KH, Lee, SK, Kim, HK, Park, JW, Park, HW, Chung, JH, Choi, BW, Lee, BJ, Chang, YS, Jo, EJ, Lee, SY, Cho, YS, Jee, YK, Lee, JM, Jung, J & Park, CS 2018, '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', Clinical Therapeutics, vol. 40, no. 7, pp. 1096-1107.e1. https://doi.org/10.1016/j.clinthera.2018.04.021
Kim, Mi Kyeong ; Lee, Sook Young ; Park, Hae Sim ; Yoon, Ho Joo ; Kim, Sang Ha ; Cho, Young Joo ; Yoo, Kwang Ha ; Lee, Soo Keol ; Kim, Hee Kyoo ; Park, Jung Won ; Park, Heung Woo ; Chung, Jin Hong ; Choi, Byoung Whui ; Lee, Byung Jae ; Chang, Yoon Seok ; Jo, Eun Jung ; Lee, Sang Yeub ; Cho, You Sook ; Jee, Young Koo ; Lee, Jong Myung ; Jung, Jina ; Park, Choon Sik. / 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. In: Clinical Therapeutics. 2018 ; Vol. 40, No. 7. pp. 1096-1107.e1.
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AU - Kim, Mi Kyeong

AU - Lee, Sook Young

AU - Park, Hae Sim

AU - Yoon, Ho Joo

AU - Kim, Sang Ha

AU - Cho, Young Joo

AU - Yoo, Kwang Ha

AU - Lee, Soo Keol

AU - Kim, Hee Kyoo

AU - Park, Jung Won

AU - Park, Heung Woo

AU - Chung, Jin Hong

AU - Choi, Byoung Whui

AU - Lee, Byung Jae

AU - Chang, Yoon Seok

AU - Jo, Eun Jung

AU - Lee, Sang Yeub

AU - Cho, You Sook

AU - Jee, Young Koo

AU - Lee, Jong Myung

AU - Jung, Jina

AU - Park, Choon Sik

PY - 2018/7/1

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N2 - 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.

AB - 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.

KW - allergic rhinitis

KW - asthma

KW - clinical trial

KW - fixed-dose combination

KW - levocetirizine

KW - montelukast

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