Montelukast Plus Levocetirizine vs Monotherapy in Asthma, Allergic Rhinitis

This article is part of Pulmonology Advisor‘s coverage of the CHEST 2018 meeting, taking place in San Antonio, Texas. Our staff will report on medical research related to COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2018.

SAN ANTONIO — A fixed-dose combination of montelukast plus levocetirizine was safe and effective for the treatment of perennial allergic rhinitis and asthma compared with montelukast alone, according to research presented at the CHEST Annual Meeting, held October 6 through October 10 in San Antonio, Texas.

A 4-week double-blind, randomized, multicenter phase 3 study was conducted to compare montelukast monotherapy vs combination therapy with montelukast plus levocetirizine in a cohort of patients with perennial allergic rhinitis and mild to moderate asthma.

Following a 1-week placebo run-in period, participants were randomly assigned to receive montelukast 10 mg/d (n=112) or montelukast 10 mg/d plus levocetirizine 5 mg/d (n=116) for 4 weeks. The primary efficacy end point was mean daytime nasal symptom score (MDNSS). Additional efficacy end points included mean nighttime nasal symptom score, mean composite symptom score, forced expiratory volume in 1 second (FEV₁), forced vital capacity (FVC), FEV₁/FVC, overall assessment of allergic rhinitis by both participants and physicians, asthma control test (ACT) score, and frequency of rescue medication use during the study period.

Of the 333 patients who were screened to participate in this study, a total of 228 eligible participants were randomly assigned to treatment. Mean patient age was 43.32±15.02 years; 66.7% of the participants were women. Demographic characteristics were similar between the 2 groups.

Compared with montelukast monotherapy, montelukast plus levocetirizine demonstrated a significant reduction in MDNSS (least squares mean ± standard error of combination vs montelukast, –0.98±0.06 vs –0.81±0.06, respectively; P = .045). Regarding all other allergic rhinitis efficacy end points, the combination therapy group experienced greater improvements compared with the montelukast monotherapy group. Similar results were reported with respect to overall assessment scores, as well as FEV₁, FVC, FEV₁/FVC, and ACT score changes from baseline in the 2 treatment arms.

Montelukast plus levocetirizine was well tolerated, with a safety profile similar to that reported for montelukast monotherapy.

The investigators concluded that the fixed-dose combination of montelukast plus levocetirizine was effective and safe for the treatment of perennial allergic rhinitis and asthma.

Reference

Park JS, Park C-S, Cho YJ, Choi BW. A randomized, multicenter, double-blind, phase III study to evaluate the efficacy and safety of a combination therapy of montelukast and levocetirizine in patients with asthma and allergic rhinitis. Presented at: CHEST Annual Meeting 2018; October 6-10, 2018; San Antonio, TX.

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