The most common and bothersome symptom of allergic rhinitis (AR) is nasal congestion.
This study assessed efficacy and safety of a once-daily tablet containing 10 mg of loratadine, an antihistamine, and 10 mg of montelukast, a leukotriene antagonist versus placebo and pseudoephedrine (PSE; 240 mg once-daily).
In a multicenter, 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.
There were no significant differences between L/M and PSE for any efficacy analysis.
Subjects treated with L/M experienced a similar incidence of adverse events versus placebo and a lower incidence of adverse events (dizziness, insomnia, jitteriness, nausea, and dry mouth) versus PSE.
Nasal decongestant activity of L/M was similar to that of PSE and better tolerated than PSE.
The authors concluded that L/M offers a safe and efficacious alternative to PSE for the treatment of nasal congestion in AR.
Medications for Allergic Rhinitis.
Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: Effects on nasal congestion. Prenner, Bruce; Anolik, Robert; Danzig, Melvyn; Yao, Ruji. Allergy and Asthma Proceedings, Volume 30, Number 3, May/June 2009 , pp. 263-269(7).