ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Respiration Disorders with a site in Korea, Republic of — 1 open to participants now, 3 under way, 1 of them phase 3. Respiration Disorders · Korea, Republic of.

Enrollment
6th of 10
223 · median 232
Started
2017
with 3 others
Phase 4
Only one
of the 13
Registered
4th of 13
by date

Among the 13 studies in Respiration Disorders with a site in Korea, Republic of, this one is the 6th largest by enrollment of the 10 interventional ones that give a count, is one of 4 that started in 2017, is the only one in phase 4, and was the 4th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

1 of the 13 studies in Respiration Disorders with a site in Korea, Republic of is open now. Recruiting first, the newest first:

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 15 Years to 74 Years · all sexes · no healthy volunteers.

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This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Respiration Disorders with a site in Korea, Republic of, or all of them as a file.
02

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.

03

Conditions studied

  • Respiratory Disease

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or allergic reaction in component of 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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

07

Study locations

1 site
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Apr 2018, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Nov 7, 2017
StartActual
Oct 27, 2017
Primary completionActual
Apr 11, 2018
CompletionActual
Oct 30, 2018
Last update
Jan 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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