Efficacy and tolerability of EPs 7630 tablets in patients with acute bronchitis: a randomised, double-blind, placebo-controlled dose-finding study with a herbal drug preparation from Pelargonium sidoides

AbstractObjective:Acute bronchitis is one of the most frequent health complaints for which patients seek medical advice. Although viral infections prevail, antibiotics are commonly prescribed. In this study, the efficacy and tolerability of EPs 7630 tablets, a herbal drug preparation from the roots of Pelargonium sidoides, were investigated in adults with acute bronchitis outside the strict indication for antibiotics.Research design and methods:In this randomised, double-blind, placebo-controlled, multicentre dose-finding trial using an adaptive group-sequential design, 406 patients were randomly assigned to one of four parallel treatment groups (10 mg EPs 7630 tablets three times a day (30-mg group), 20 mg EPs 7630 tablets three times a day (60-mg group), 30 mg EPs 7630 tablets three times a day (90-mg group) or placebo three times a day) for a treatment period of 7 days. Primary endpoint was the change in the total score of bronchitis-specific symptoms (BSS) from baseline to day 7.Results:Between day 0 ...