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

NCT ID: NCT03334916

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-27
• Study Completion Date: 2018-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

YMC026

108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days.

Group Type: EXPERIMENTAL

YMC026

Intervention Type: DRUG

YMC026 20mL TID

Placebo

108 subjects will be assigned in this group. They will be administered 20mL of placebo three times a day for 6 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 20mL TID

Interventions

YMC026

YMC026 20mL TID

Intervention Type: DRUG

Placebo

Placebo 20mL TID

Intervention Type: DRUG

Eligibility Criteria

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 β2-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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YMC026

Identifier Type: -

Identifier Source: org_study_id