The efficacy and safety of DW1601 in patients with acute bronchitis: a multi-center, randomized, double-blind, phase III clinical trial.

"This trial was supported by Daewon Pharmaceutical company, Republic of Korea. This sponsor provided support for laboratory tests, transportation cost of patients, ECG/Chest X-ray, and investigational products."

"This trial was supported by Daewon Pharmaceutical company, Republic of Korea. This sponsor provided support for laboratory tests, transportation cost of patients, ECG/Chest X-ray, and investigational products."

"This study was a multi-centre, randomized, double-blind, parallel, active controlled phase III clinical trial to evaluate the efficacy and safety of DW1601 compared to DW16011 or P. sidoides in patients with acute bronchitis. This study was conducted in six institutions in Republic of Korea between December 2018 and December 2019. This study consisted of a screening visit (visit 1), a baseline visit (visit 2), a Day 4 ± 1 day visit (visit 3), and an end of treatment visit on Day 7 ± 1 day (visit 4). The primary outcome was efficacy of DW1601 compared to that of DW16011 or P. sidoides in reducing the bronchitis severity score (BSS) at 4 days after medication in patients with acute bronchitis [,]. The secondary outcome was to assess the efficacy of DW1601 compared to DW16011 or P. sidoides in reducing total BSS at 7 days and in relief of each symptom through BSS assessment at 4 and 7 days post-treatment and to assess patient satisfaction with improvement of symptoms at 4 and 7 days post-treatment. This study protocol was uploaded to Clinicaltrial.gov before the beginning of the study (Number: NCT04260555). The study protocol, available in , was approved by the Institutional Review Boards of all applicable institutions (Korea University Guro Hospital, IRB number: 2018GR0369; Kangbuk Samsung Hospital, KBSMC2018-11-010). This study was conducted in accordance with the Declaration of Helsinki and the international conference on harmonization-good clinical practice. We ensured protection of patient privacy and anonymity. All patients provided written informed consent before enrollment, and the study was monitored by an independent data and safety monitoring committee."