Publication:

Evaluation of efficacy of fixed dose combination of montelukast and levocetirizine compared to monotherapy of montelukast and levocetirizine in patients with seasonal allergic rhinitis

Background Allergic rhinitis (AR) is a global health problem. Almost 10%–25% of population worldwide is affected by AR. Seasonal allergic rhinitis (SAR) is caused by an IgE-mediated reaction to seasonal aeroallergens and is fairly easy to identify because of the rapid and reproducible onset and offset of symptoms in association with pollen exposure. SAR can result in hyperresponsiveness to allergens. Treatment of allergic rhinitis is aimed to achieve optimal symptom control and reduce nasal congestion, sneezing and rhinorrhea over the course of the entire day and night.

Methods Out of total 274 subjects, 92 subjects in the FDC of montelukast 10 mg and levocetrizine 5 mg group, 92 subjects in montelukast 10 mg group and 90 subjects in levocetrizine 5 mg group were enrolled in the study. The total study duration was 16 days. Criteria for evaluation of primary efficacy were mean change in daytime nasal symptoms score from baseline to end of treatment. Mean change in night time symptoms score from baseline to end of treatment. Mean change in daytime eye symptoms score from baseline to end of treatment. Patient's and physician's global evaluation of allergic rhinitis at the end of treatment. Mean change in rhinoconjunctivitis quality-of life score from baseline to end of treatment.

Results Primary efficacy endpoint that fixed dose combination (FDC) of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5mg monotherapy in the treatment of patients with seasonal allergic rhinitis. Other secondary endpoints and global impression results are also supporting the therapeutic benefit of fixed dose combination over monotherapy.

Conclusions FDC of montelukast 10 mg and levocetirizine 5 mg was superior to montelukast 10 mg monotherapy or levocetirizine 5 mg monotherapy in the treatment of patients with seasonal allergic rhinitis.