Study objective: To assess the efficacy and tolerability of a fixed fluid extract combination of thyme and ivy leaves (thyme-ivy combination) and matched placebo in patients suffering from acute bronchitis with productive cough.
Methods: In a double-blind, placebo-controlled, multicentre Phase IV study 361 outpatients with acute bronchitis and > or =10 coughing fits during the day, onset of bronchial mucus production with impaired ability to cough up at a maximum of 2 days prior to recruitment, and a Bronchitis Severity Score (BSS) > or =5 score points were randomly assigned to an 11-day treatment (5.4 ml three times daily) with either thyme-ivy combination syrup (Bronchipret Saft; N=182) or placebo syrup (N=179). After the baseline examination (Visit 1 = Day 0), 2 control examinations were scheduled (Visit 2 = Day 4; Visit 3 = Day 10/end of treatment). The efficacy of study treatment on acute bronchitis was evaluated by the patient's daily counting of coughing fits during the daytime (manual counter), assessment of acute bronchitis related symptoms and by the investigator's assessment of the most important symptoms of acute bronchitis using the BSS. Evaluation of tolerability was based upon adverse event (AE) monitoring, measurement of vital signs as well as the Primary outcome was the change in frequency of coughing fits during daytime on days 7-9 according to patient's accurate daily recording with a manual counter and documentation in the diary. Treatment effects were analysed by analysis of variance (ANOVA) adjusted for centre effects. Due to significant deviation from the "preconditions" of the ANOVA, the Wilcoxon test (stratified by centre) was carried out additionally.
Results: The mean reduction in coughing fits on days 7 to 9 relative to baseline was 68.7% under thyme-ivy combination compared to 47.6 % under placebo (p < 0.0001). In the thyme-ivy combination group, a 50% reduction in coughing fits from baseline was reached 2 days earlier compared to the placebo group. The symptoms of acute bronchitis (BSS) improved rapidly in both groups, but regression of symptoms was faster and the responder rates (p < 0.0001) compared to placebo were higher at Visit 2 (83.0% vs 53.9%) and Visit 3 (96.2% vs. 74.7%) under the treatment of thyme-ivy combination. Treatment was well tolerated with no difference in the frequency or severity of AEs between thyme-ivy combination and placebo groups. Severe or serious AEs were not reported.
Conclusion: Oral treatment of acute bronchitis with thyme-ivy combination for about 11 days was superior to pla-