Therapeutic approaches to the common cold in children.

In a five-day, randomized, double-blind study, the efficacy and safety of a syrup containing a combination of azatadine maleate, pseudoephedrine sulfate, and dextromethorphan hydrobromide (SCH 399 syrup) were compared with those of an expectorant containing the antihistamine diphenhydramine hydrochloride in 60 children with symptoms of the common cold and associated cough. One-half teaspoonful of assigned medication was administered three or four times daily. The severity of signs and symptoms was graded on days 0, 3, and 5. At days 3 and 5, patients treated with SCH 399 experienced a significantly greater degree of relief (P less than 0.001) than did patients treated with the expectorant product. Differences between treatment groups in overall therapeutic response, as evaluated by the physician, were statistically significant (P less than 0.001) at each visit, favoring patients treated with SCH 399. More than 75% of the patients treated with SCH 399 demonstrated an excellent therapeutic response. Tolerance to both study medications was excellent.