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

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ClinicalTrials.gov Identifier: NCT03334916
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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

Condition or disease Intervention/treatment Phase
Respiratory Disease Drug: YMC026 Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: YMC026
108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days.
Drug: YMC026
YMC026 20mL TID

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




Primary Outcome Measures :
  1. Change from Baseline BSS at Day 6 [ Time Frame: Baseline(Day 0), Day 6 ]
    Bronchitis Severity Score


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334916


Contacts
Contact: Young Kyoon Kim, M.D., Ph.D. MD youngkim@catholic.ac.kr
Contact: Jeong-Woong Park, M.D., Ph.D. MD jwpark@gilhospital.com

Locations
Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03334916     History of Changes
Other Study ID Numbers: YMC026
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases