BROMPHENIRAMINE, TERFENADINE, AND PLACEBO IN ALLERGIC RHINITIS

Background: Second-generation antihistamines, reported to lack central nervous system depressant activity, may be considered to have a clini cal advantage over traditional antihistamines. Objective: To compare t he effectiveness, at recommended doses, of an extended-release formula tion of nonprescription brompheniramine and prescription terfenadine i n the treatment of allergic rhinitis. Methods: This was a double-blind , randomized, placebo-controlled, multicenter, parallel study. Subject s with symptoms of allergic rhinitis received brompheniramine 12 mg (n = 96), terfenadine 60 mg (n = 96), or placebo (n = 95) twice daily fo r 14 days. Subjects returned on treatment days 3, 7, and 14; at which times, the investigator assessed symptom severity (ie, rhinorrhea; sne ezing; nasal blockage; pruritus of the eyes, nose, or pharynx; watery eyes; and postnasal drip). The investigator and the subject each compl eted a global efficacy evaluation, and subjects were interviewed regar ding the occurrence of adverse experiences. Symptoms were analyzed as summed severity scores for (1) all symptoms and (2) for the symptom cl uster of rhinorrhea, sneezing, and nasal blockage. Results: At all pos t-baseline evaluations (days 3, 7, and 14), brompheniramine was signif icantly better (P less than or equal to .05) than terfenadine and plac ebo for both sets of summed symptom scores and for both global assessm ents. Terfenadine was significantly better (P less than or equal to .0 5) than placebo on the physician's global at day 14. Central nervous s ystem-related complaints were the most frequently reported adverse exp eriences among all three groups; somnolence was reported most frequent ly by brompheniramine-treated subjects. Conclusion: A nonprescription, extended-release formulation of brompheniramine, 12 mg bid, provided significantly better relief of symptomatic allergic rhinitis than terf enadine, 60 mg bid.