A double-blind, randomized, placebo-controlled multi-center, multinational study evaluating the efficacy and safety of Tavipec® capsules in acute bronchitis
Spikeoil (Tavipec®) is a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia. The trial was designed to evaluate the efficacy and safety of Tavipec® in patients suffering from acute bronchitis.
Patients with acute bronchitis without any confounding respiratory disease were randomly assigned to treatment with Tavipec® 150mg 2 capsules 3 times daily or placebo in a double-blind, parallel-group design. No additional treatment (Antibiotics, corticosteroids etc.) was admitted. The primary endpoint, the bronchitis severity score (BSS) = 5 score points was evaluated by the investigator at baseline and after 7 days of treatment. Secondary endpoints included the BSS at day 10, additional signs and symptoms of bronchitis, Quality of life (QoL) and safety evaluated at day 7 and day 10.
269 patients were enrolled and 245 (Tavipec®: 125; Placebo: 120) patients remained for statistical analysis. The mean decrease in BSS from baseline to day 7 was 4.54 (SD 2.34) and 2.92 (SD 2.64) for treatment with Tavipec® and placebo. The difference of the BSS between Tavipec® and placebo is significant (p = 0.00014). The improvement of BSS from baseline to day 10 was higher 6.48 (SD 2.17) versus 4.33 (SD 2.96) under the treatment of Tavipec® (p = 0.00003) The Quality of Life of the patients was significantly improved under the treatment of Tavipec® compared to placebo at day 7 and day 10. The treatment with Tavipec® was safe and well tolerated.
These results show that the treatment of acute bronchitis with Spikeoil (Tavipec®) is statistically superior to placebo and is well tolerated.