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

NCT03334916 | Completed Phase 4

• 1 other identifier: YMC026
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline BSS at Day 6

  Bronchitis Severity Score

  Baseline(Day 0), Day 6

Secondary Outcomes (2)

• Change from Baseline BCSS at Day 6

  Baseline(Day 0), Day 6

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

  Day 6

Study Arms (2)

YMC026

EXPERIMENTAL

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

Drug: YMC026

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

YMC026 DRUG

YMC026 20mL TID

YMC026

Placebo DRUG

Placebo 20mL TID

Placebo

Eligibility Criteria

• Age: 15 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 7, 2017
• Study Start: October 27, 2017
• Primary Completion: April 11, 2018
• Study Completion: October 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

KR (1)