Respiratory DiseasePhase 4NCT03334916
A Clinical Trial to Evaluate the Efficacy and Safety of YMC026 in Respiratory Disease Patients
A Phase 4 study testing YMC026 in people with Respiratory Disease, run by Yuhan Corporation at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- YMC026
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2017to 30 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul
About this study
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
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.
- Conditions
- Respiratory Disease
- Being tested
- YMC026, Placebo
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMC026Drug
YMC026 20mL TID
PlaceboDrug
Placebo 20mL TID
| Study group | Role | What they receive |
|---|---|---|
| YMC026 | Experimental | 108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline BSS at Day 6
Bronchitis Severity Score
Measured: Baseline(Day 0), Day 6
Secondary outcomes (2)
Change from Baseline BCSS at Day 6
Breathlessness, Cough, and Sputum Scale
Measured: Baseline(Day 0), Day 6
Patients´ evaluation of symptoms of cough and sputum on patient's diary
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start27 Oct 2017
- Primary completion11 Apr 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334916
- Sponsor's protocol ID
- YMC026
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03334916
- Acronym / sponsor ID
- YMC026
- Conditions
- Respiratory Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YMC026 | Experimental | Drug: YMC026108 subjects will be assigned in this group. They will be administered 20mL of YMC026 three times a day for 6 days. |
| Placebo | Placebo comparator | Drug: Placebo108 subjects will be assigned in this group. They will be administered 20mL of placebo three times a day for 6 days. |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YMC026YMC026 20mL TID | Drug | YMC026 |
| PlaceboPlacebo 20mL TID | Drug | Placebo |
Primary outcome
Change from Baseline BSS at Day 6
Time frame: Baseline(Day 0), Day 6
Bronchitis Severity Score
2 secondary outcomes
Change from Baseline BCSS at Day 6
Time frame: Baseline(Day 0), Day 6
Patients´ evaluation of symptoms of cough and sputum on patient's diary
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing YMC026 in people with Respiratory Disease, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline BSS at Day 6 (time frame: Baseline(Day 0), Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.