Chronic Obstructive Pulmonary DiseasePhase 2NCT06434792
Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Bronpass Tab. in people with Chronic Obstructive Pulmonary Disease, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bronpass Tab.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to Mar 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years ≤ age
- Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
- Patients who meet all of the following criteria at the screening test
- FEV1/FVC < 0.70 after bronchodilator administration
- 30% ≤ FEV1 < 80% predicted after bronchodilator administration
- Cough or sputum-related score on the CAT ≥ 3
- Current or former smokers with a smoking history of 10 pack-years or more at screening.
- Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.
Who cannot join
- Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
- Patients with a medical history of respiratory diseases other than COPD
- Patients who have undergone lung volume reduction surgery.
- Patients with a history of lung transplantation.
- Patients with a history of respiratory infections within 4 weeks prior to screening
- Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
- Pregnant or lactating women.
- Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University School of Medicine
Seoul, 05030
Kwang Ha Yoo, MD, PhD, 82-2-2030-5114, 20130643@kuh.ac.kr
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD
This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.
Read the detailed description
This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bronpass Tab., Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronpass Tab.Drug
Also called HL301
Twice daily for 12 weeks
PlaceboOther
Twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bronpass Tab. | Experimental | Twice daily for 12 weeks Receives: Drug: Bronpass Tab. |
| Placebo | Placebo comparator | Twice daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
Measured: Time frame: 3 months(Visit 5)
Secondary outcomes (7)
Change from baseline in CAT total score at Visit 3 and Visit 4
Measured: Time frame: 1 month(Visit 3), 2 months(Visit 4)
Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5
Measured: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
Measured: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Incidence of moderate and severe COPD exacerbations from baseline to Visit 5
Measured: Time frame: 3 months(Visit 5)
Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5
Measured: Time frame: 3 months(Visit 5)
Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5
Measured: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5
Measured: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2023
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwang Ha Yoo, MD, PhD, Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434792
- Sponsor's protocol ID
- HL_HL301_204
- Status last verified
- May 2024
- First submitted
- 18 Sep 2023
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD
- ClinicalTrials.gov ID
- NCT06434792
- Acronym / sponsor ID
- HL_HL301_204
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 May 2024 (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 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.
Detailed description
This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronpass Tab. | Experimental | Drug: Bronpass Tab.Twice daily for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboTwice daily for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 40 years ≤ age
- Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
- Patients who meet all of the following criteria at the screening test
- Current or former smokers with a smoking history of 10 pack-years or more at screening.
- Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.
Key exclusion criteria (8 listed)
- Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
- Patients with a medical history of respiratory diseases other than COPD
- Patients who have undergone lung volume reduction surgery.
- Patients with a history of lung transplantation.
- Patients with a history of respiratory infections within 4 weeks prior to screening
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 |
|---|---|---|
| Bronpass Tab.Also: HL301Twice daily for 12 weeks | Drug | Bronpass Tab. |
| PlaceboTwice daily for 12 weeks | Other | Placebo |
Primary outcome
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
Time frame: Time frame: 3 months(Visit 5)
7 secondary outcomes
Change from baseline in CAT total score at Visit 3 and Visit 4
Time frame: Time frame: 1 month(Visit 3), 2 months(Visit 4)
Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5
Time frame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
Time frame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Incidence of moderate and severe COPD exacerbations from baseline to Visit 5
Time frame: Time frame: 3 months(Visit 5)
Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5
Time frame: Time frame: 3 months(Visit 5)
Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5
Time frame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5
Time frame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Kwang Ha Yoo, MD, PhD principal investigator
Konkuk University
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 Bronpass Tab. in people with Chronic Obstructive Pulmonary Disease, run by Hanlim Pharm. Co., Ltd. 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwang Ha Yoo, MD, PhD (82-2-2030-5114, 20130643@kuh.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5 (time frame: Time frame: 3 months(Visit 5)). 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 30 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.