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

Primary Purpose

Respiratory Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YMC026

Placebo

About this trial

This is an interventional treatment trial for Respiratory Disease

Eligibility Criteria

15 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

YMC026

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline BSS at Day 6

Bronchitis Severity Score

Secondary Outcome Measures

Change from Baseline BCSS at Day 6

Breathlessness, Cough, and Sputum Scale

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

Full Information

NCT ID

NCT03334916

First Posted

October 31, 2017

Last Updated

January 14, 2019

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03334916

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 27, 2017 (Actual)

Primary Completion Date

April 11, 2018 (Actual)

Study Completion Date

October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

223 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YMC026

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

YMC026

Intervention Description

YMC026 20mL TID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 20mL TID

Primary Outcome Measure Information:

Title

Change from Baseline BSS at Day 6

Description

Bronchitis Severity Score

Time Frame

Baseline(Day 0), Day 6

Secondary Outcome Measure Information:

Title

Change from Baseline BCSS at Day 6

Description

Breathlessness, Cough, and Sputum Scale

Time Frame

Baseline(Day 0), Day 6

Title

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

Time Frame

Day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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