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NCT Number: NCT03334916

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

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

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Key information

Age range

15 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender, 15 years ≤ age < 75 years
  • Patients with BSS(Bronchitis Severity Score) ≥ 5point at screening visit and randomization visit
  • Written consent voluntarily to participate in this clinical trial

Exclusion criteria

  • Patients with severe respiratory disease
  • Patients with severe pulmonary disease
  • Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
  • Patients with pregnant and/or have breast feeding
  • Patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product
  • Patients who were treated with β2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product
  • Patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product
  • Patients who are participating in another trial within 30 days prior to screening visit
  • Patients who investigators determines not appropriate to take part in this clinical study

Treatment and study plan

YMC026

Drug

YMC026 20mL TID

Placebo

Drug

Placebo 20mL TID

Primary outcomes

  1. Change from Baseline BSS at Day 6

    Time frame: Baseline(Day 0), Day 6

    Bronchitis Severity Score

Secondary outcomes

  1. Change from Baseline BCSS at Day 6

    Time frame: Baseline(Day 0), Day 6

    Breathlessness, Cough, and Sputum Scale

  2. Patients´ evaluation of symptoms of cough and sputum on patient's diary

    Time frame: Day 6

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2017
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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