Acute BronchitisPhase 2NCT01420445
Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis
A Phase 2 study testing YHD001 dose level 1, YHD001 dose level 2 and Pelargonium sidoides extract in people with Acute Bronchitis and Chronic Bronchitis, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days. The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bronchitis, Chronic Bronchitis
- What is being tested?
- YHD001 dose level 1, YHD001 dose level 2 and Pelargonium sidoides extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged ≥18 year
- Provision of written informed consent
- Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points
Who cannot join
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, 137-701
About this study
Official title: Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.
The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
Read the detailed description
The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.
- Conditions
- Acute Bronchitis, Chronic Bronchitis
- Being tested
- YHD001 dose level 1, YHD001 dose level 2, Pelargonium sidoides extract, placebo
- Medical subject headings
- Bronchitis, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHD001 dose level 1Drug
Also called Undecided
three times daily / 7 days
YHD001 dose level 2Drug
Also called Undecided
three times daily / 7 days
Pelargonium sidoides extractDrug
Also called UMCKAMIN Syrup
6-9mL three times daily / 7 days
placeboDrug
three times daily / 7 days
| Study group | Role | What they receive |
|---|---|---|
| YHD001 dose level 1 | Experimental | YHD001 dose level 1 Receives: Drug: YHD001 dose level 1 |
| YHD001 dose level 2 | Experimental | YHD001 dose level 2 Receives: Drug: YHD001 dose level 2 |
| Pelargonium sidoides extract | Active comparator | Pelargonium sidoides extract (Syrup) Receives: Drug: Pelargonium sidoides extract |
| Placebo | Placebo comparator | Placebo for YHD001 \& active comparator(syrup) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total symptom score from baseline to the end of treatment
Measured: 7 days
Secondary outcomes (3)
safety assessment
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
Measured: 7 days
time to response
Measured: 7 days
compliance, defined by drug accountability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Kyoon Kim, M.D., Ph.D., Principal investigator, Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420445
- Sponsor's protocol ID
- YHD001-202
- Status last verified
- Sep 2013
- First submitted
- 20 Jul 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT01420445
- Acronym / sponsor ID
- YHD001-202
- Conditions
- Acute Bronchitis, Chronic Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- 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.
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.
The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
Detailed description
The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YHD001 dose level 1 | Experimental | Drug: YHD001 dose level 1YHD001 dose level 1 |
| YHD001 dose level 2 | Experimental | Drug: YHD001 dose level 2YHD001 dose level 2 |
| Pelargonium sidoides extract | Active comparator | Drug: Pelargonium sidoides extractPelargonium sidoides extract (Syrup) |
| Placebo | Placebo comparator | Drug: placeboPlacebo for YHD001 \& active comparator(syrup) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged ≥18 year
- Provision of written informed consent
- Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points
Key exclusion criteria (3 listed)
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Use of antibiotics, anti-histamine during the 7 days before administration of the 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 |
|---|---|---|
| YHD001 dose level 1Also: Undecidedthree times daily / 7 days | Drug | YHD001 dose level 1 |
| YHD001 dose level 2Also: Undecidedthree times daily / 7 days | Drug | YHD001 dose level 2 |
| Pelargonium sidoides extractAlso: UMCKAMIN Syrup6-9mL three times daily / 7 days | Drug | Pelargonium sidoides extract |
| placebothree times daily / 7 days | Drug | Placebo |
Primary outcome
Change of total symptom score from baseline to the end of treatment
Time frame: 7 days
3 secondary outcomes
safety assessment
Time frame: 7 days
time to response
Time frame: 7 days
compliance, defined by drug accountability
Time frame: 7 days
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 26 Sep 2013.
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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.
Young Kyoon Kim, M.D., Ph.D. principal investigator
Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YHD001 dose level 1, YHD001 dose level 2 and Pelargonium sidoides extract in people with Acute Bronchitis and Chronic Bronchitis, 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 3 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 26 Sep 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 of total symptom score from baseline to the end of treatment (time frame: 7 days). 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 26 Sep 2013.