Relieving symptoms of upper respiratory allergies and the common cold: azatadine maleate/pseudoephedrine sulfate syrup versus placebo.

A total of 132 patients with symptoms associated with either upper respiratory allergies or the common cold was enrolled in this 5-day study. Azatadine maleate/pseudoephedrine sulfate syrup was compared to placebo using a double-blind design. Evaluation of efficacy was based on results in eighty patients and that of safety in 115. Onset of relief was significantly better (p = 0.03) with azatadine maleate/pseudoephedrine sulfate syrup than with placebo. However this was due mainly to the distribution of patients who indicated 'no relief': ten in the combination group as opposed to sixteen in the placebo group. Over-all evaluation of results indicated that a significantly greater degree of symptomatic relief was achieved with the active test formulation than with placebo on both Days 3 (p = 0.03) and 5 (p = 0.04) of therapy. Somnolence was the most frequently reported side-effect.

RCT Entities:   Population Interventions Outcomes