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

Respiratory Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334916
• Other study ID #: YMC026
• Status: Completed
• Phase: Phase 4
• Start date: October 27, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: October 30, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Both gender, 15 years = age < 75 years

2. Patients with BSS(Bronchitis Severity Score) = 5point at screening visit and randomization visit

3. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with severe respiratory disease

2. Patients with severe pulmonary disease

3. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug

4. Patients with pregnant and/or have breast feeding

5. Patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product

6. Patients who were treated with ß2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product

7. Patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product

8. Patients who are participating in another trial within 30 days prior to screening visit

9. Patients who investigators determines not appropriate to take part in this clinical study

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Drug:
• YMC026
YMC026 20mL TID
• Placebo
Placebo 20mL TID

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline BSS at Day 6	Bronchitis Severity Score	Baseline(Day 0), Day 6
Secondary	Change from Baseline BCSS at Day 6	Breathlessness, Cough, and Sputum Scale	Baseline(Day 0), Day 6
Secondary	Patients´ evaluation of symptoms of cough and sputum on patient's diary		Day 6