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.
D000293:Adolescent; D000328:Adult; D000368:Aged; D003139:Common Cold / Q000188:drug therapy*; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004341:Drug Evaluation; D004809:Ephedrine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012130:Respiratory Hypersensitivity / Q000188:drug therapy*
D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D010919:Placebos; D003533:Cyproheptadine; C006656:azatadine; D004809:Ephedrine