Montelukast/Levocetirizine Combination Therapy Yields Effective in Phase 3 Trial

FDA-BW.jpg Data from the phase 3 clinical trial investigating the combination of montelukast and levocetirizine compared to montelukast alone in patients perennial allergic rhinitis with mild-to-moderate asthma were released at the 2018 CHEST Annual Meeting in San Antonio, TX.

Among the combination therapy’s highlights were observed safety and efficacy, suggesting the fixed-dose of montelukast and levocetirizine may be a safe and effective treatment for patients with perennial allergic rhinitis who also have asthma.

The 4-week, randomized, multicenter, double-blind, phase 3 clinical trial sought to establish the safety and efficacy of a fixed-dose combination of montelukast and levocetirizine for patients with perennial allergic rhinitis with mild-to-moderate asthma. The trial also sought to compare the combination therapy to montelukast alone for the same patient population.

After a 1-week placebo run-in period, patients were randomized to be administered montelukast (10 mg/day, n = 112) or montelukast (10 mg/day)/levocetirizine (5 mg/day, n = 116) treatment for 4 weeks.

Daytime nasal symptom score (MDNSS) served as the primary efficacy endpoint.

Additional efficacy endpoints included mean nighttime nasal symptom score (MNNSS), mean composite symptom score (MCSS), forced vital capacity (FVC), FEV1/FVC, overall assessment of allergic rhinitis by both subjects and physicians, forced expiratory volume in 1 second (FEV1), asthma control test (ACT) score, and the frequency of rescue medication used during the treatment period.

A total of 333 patients were screened for the study, and 228 patients were deemed eligible and randomized for treatment.

Two-thirds of the participating patients were women (66.67%), and the mean (SD) age of patients was 43.32 (15.02) years. Between the treatment groups, demographic characteristics were similar.

Upon analysis, data showed the montelukast/levocetirizine group demonstrated significant reduction in MDNSS compared to that of the montelukast group (least squares mean ± standard error of combination versus montelukast, -0.98 ± 0.06 vs. -0.81 ± 0.06, p = 0.045).

The montelukast/levocetirizine group also showed greater improvement than the montelukast group did for all the other allergic rhinitis efficacy endpoints.

From baseline for the 2 treatment groups, similar results were displayed in overall assessment scores and in FEV1, FVC, FEV1/FVC, and ACT score changes.

Aside from being well tolerated, the montelukast/levocetirizine combination therapy’s safety profile was similar to that seen in the montelukast group.

From the data, study authors concluded the fixed-dose combination of montelukast and levocetirizine to be effective and safe for the treatment of perennial allergic rhinitis patients with asthma.

While the montelukast/levocetirizine combination therapy proved to be more effective than Montelukast alone in the phase 3 trial, montelukast has been previously shown to ease asthma symptoms in the youngest of patients independently.

In the randomized controlled trial conducted in Japan, montelukast caused fewer asthma symptom exacerbations in treated preschool children compared to as-needed beta 2-agonist bronchodilator.

Additionally, montelukast has been studied as a component in other combination therapies, such as with budesonide. Besides a lack of serious adverse events, the montelukast/budesonide combination therapy’s FEV₁ increased from baseline to 8 weeks by approximately 17%.

Whether alone or in combination, montelukast’s proven efficacy makes it an exciting enterprise as a treatment.

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The abstract, "A Randomized Multicenter, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients with Asthma and Allergic Rhinitis” was presented at the CHEST 2018 annual meeting.