The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial.

"data sharing statement: available at http://dx doi"

"Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd-20-1567). Dr. SYK, Dr. PhD. YYL and Ms. SJP report personal fees from CKD pharm, during the conduct of the study. The other authors have no conflicts of interest to declare."

"Funding: CKD Pharm."

"The trial included subjects with cough and phlegm caused by AURI and AB. This was a randomized, double-blind, placebo- and active component-controlled, four-group parallel design trial conducted in 15 centers in Korea from June 8, 2018 (when the first patient was enrolled) to March 21, 2019 (when the last patient was enrolled). The trial was conducted according to the principles of the Declaration of Helsinki and Korean Good Clinical Practice guidelines, and written informed consent was obtained from all patients. The trial protocol was approved by the Korean Food and Drug Administration (approval no. 176AURI/AB17014) and by the institutional and review board (IRB) at each center. This study was registered in the Clinical Trials Registry in Korea (31630) and Clinicaltrial.gov (NCT03726853) before the enrollment was started."