Efficacy of once-daily desloratadine/pseudoephedrine for relief of nasal congestion.

The majority of patients with seasonal allergic rhinitis (SAR) suffer from nasal congestion. Desloratadine, a nonsedating H 1 -receptor antagonist, has given decongestant relief to patients with mild-to-moderate nasal congestion associated with SAR. The following study was undertaken to show that a once-daily formulation of desloratadine/pseudoephedrine would provide greater decongestant relief to patients experiencing moderate-to-severe nasal congestion compared with component monotherapy. A total of 1018 patients were assigned randomly to receive desloratadine/ pseudoephedrine (5 mg/240 mg), desloratadine (5 mg), or pseudoephedrine (240 mg) daily for 15 days. Over the 15-day study period, patients receiving desloratadine/pseudoephedrine combination tablets had a significant reduction in mean A.M./P.M. reflective nasal congestion scores compared with patients receiving desloratadine or pseudoephedrine (p < 0.01); this reduction reached significance by day 2. Desloratadine/pseudoephedrine combination tablets also produced a greater reduction in A.M. instantaneous nasal congestion scores compared with component monotherapy (p < 0.01), indicating not only superior efficacy but also a full 24-hour effect. Desloratadine monotherapy reduced all mean nasal congestion scores to a similar degree as compared with pseudoephedrine monotherapy (p = NS). No unusual or unexpected adverse events were reported in any group. It was concluded that desloratadine/pseudoephedrine offers additional benefit to patients with moderate-to-severe SAR-associated nasal congestion compared with pseudoephedrine therapy alone.