Efficacy and tolerability of ebastine 10 mg plus pseudoephedrine 120 mg in the symptomatic relief of the common cold.
Background: The objective of this multicenter, parallel, double-blind, placebo-controlled clinical trial was to determine the efficacy and tolerability of the combination of ebastine 10 mg plus pseudoephedrine 120 mg once daily after 3 days of treatment in the symptomatic relief of patients with a common cold. Methods: The principal variable studied was the evaluation of overall efficacy and secondary variables were improvement of the patient, evolution of symptoms, disposition of the patient to take the medication again, and variation in nasal peak flow. Results: The percentage of subjects showing a good or excellent treatment efficacy was significantly higher in the group treated with ebastine plus pseudoephedrine (75.8%) than in the group treated with placebo (57.6%; p<0.001). Statistically significant differences were also found in favor of ebastine plus pseudoephedrine when comparing the changes in the sum of scores for nasal and ocular symptoms (p<0.006) or total symptoms (p<0.0016). The tolerability of the active treatment studied was good; that is, no significant differences were found between ebastine 10 mg plus pseudoephedrine 120 mg and placebo. Most adverse events described were slight or moderate in intensity, and no serious adverse events were reported. Conclusions: The combination of ebastine 10 mg immediate release and pseudoephedrine 120 mg sustained release was found effective in the symptomatic treatment of patients suffering from a common cold and as safe as placebo.
Almirall Prodesfarma S.A., Research Centre, C/ Cardener 68-74, Barcelona 08024, Spain.
M.
M
Robert
M.
M
Llorens
E.
E
García
X.
X
Luria