NCT03334916

A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients With Cough and Sputum as the Main Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 15 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the efficacy and safety of YMC026 in respiratory disease patients with cough and sputum as the main symptoms

Detailed description

The study has planned 4 visits during 2 weeks period (1 week of screening period, 1 week of treatment period). All subjects who agree to participate in the study and voluntarily give written informed consent are assessed by inclusion and exclusion criteria at the screening visit. After the screening period, the final eligibility of the subjects will be assessed at the randomization visit. Subjects who are determined to be appropriate for this study will be allocated to experimental group(YMC026) or control group(placebo) randomly in a 1:1 ratio. Subject will be administered the investigational product daily for 6 days. The safety for the subjects will be assessed at Day 3 and Day 6 visit, and the efficacy evaluation will be assessed at Day 6 visit.

Conditions

• Respiratory Disease

Interventions

Type	Name	Description
DRUG	YMC026	YMC026 20mL TID
DRUG	Placebo	Placebo 20mL TID

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-04-11
• Completion: 2018-10-30
• First posted: 2017-11-07
• Last updated: 2019-01-16

Locations

1 site across 1 country: South Korea