Montelukast sodium and levocetirizine

  1. Montelukast Plus Levocetirizine vs Monotherapy in Asthma, Allergic Rhinitis


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Montelukast Plus Levocetirizine vs Monotherapy in Asthma, Allergic Rhinitis

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 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 (FEV 1), forced vital capacity (FVC), FEV 1/FVC, overall assessment of 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 rhiniti...