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CompletedNCT03334916Updated Jan 16, 2019

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

A Phase 4 interventional study of YMC026 and Placebo in Respiratory Disease, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 15 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Yuhan Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
223
Allocation
Randomized
Ages
15 Years to 74 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Respiratory Disease
03

Who can participate

Ages eligible
15 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
223 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugYMC026

    YMC026 20mL TID

  • DrugPlacebo

    Placebo 20mL TID

05

What researchers measure

Primary outcomes

  1. Change from Baseline BSS at Day 6

    Bronchitis Severity Score

    Time frame: Baseline(Day 0), Day 6

Secondary outcomes

  1. Change from Baseline BCSS at Day 6

    Breathlessness, Cough, and Sputum Scale

    Time frame: Baseline(Day 0), Day 6

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

    Time frame: Day 6

06

Study locations

1 site
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03334916
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Oct 27, 2017
Primary completion
Apr 11, 2018
Completion
Oct 30, 2018
Last update
Jan 16, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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