A need exists for safe, effective therapy for the relief of the symptoms of allergic rhinitis (AR) that also consistently relieves nasal congestion, the most common and bothersome symptom. This study was performed to assess efficacy and safety of a once-daily tablet containing 10 mg of loratadine, an antihistamine, and 10 mg of montelukast, a leukotriene antagonist (SCH 445761) versus placebo and pseudoephedrine (PSE; 240 mg once-daily formulation; active comparator). In a multicenter, parallel-group, double-blind, double-dummy, randomized study, 1095 subjects with documented history of seasonal AR and positive skin-prick test to a prevailing aeroallergen were treated for 15 days with fixed-dose combination loratadine/montelukast (L/M), PSE, or placebo. After randomization, subjects rated severity of nasal congestion and measured peak nasal inspiratory flow (PNIF) rate in the morning and evening. The change in quality of life from baseline was also assessed. L/M and PSE were significantly more effective than placebo in alleviating nighttime and daytime nasal congestion and improving PNIF rate, an objective measure of nasal obstruction. There were no significant differences between L/M and PSE for any efficacy analysis including improvement in the quality of life. Subjects treated with L/M experienced a similar incidence of total adverse events versus placebo and a lower incidence of total adverse events (including dizziness, insomnia, jitteriness, nausea, and dry mouth) versus PSE. Nasal decongestant activity of L/M was significantly higher than that of placebo and similar to that of PSE in symptomatic AR subjects. L/M showed a safety profile similar to placebo and was better tolerated than PSE. Thus, L/M offers a safe and efficacious alternative to PSE for the treatment of nasal congestion associated with AR.
Trial registration: ClinicalTrials.gov NCT00319995.