Acute BronchitisPhase 4NCT06038084
Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule
A Phase 4 study testing Bronpass Tab. and Erdos capsule in people with Acute Bronchitis, run by Kwang-Ha Yoo at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- Bronpass Tab. and Erdos capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2022to 16 May 2023
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 19 to 80 at the time of screening
- Patients with an acute bronchitis severity score (BSS) of 5 or higher at the time of screening and the first day of administration of the investigational drug
- Patients with symptoms of acute bronchitis within 48 hours from the time of screening
- Patients who voluntarily gave written consent to participate in this clinical trial
Who cannot join
- Patients with a known hypersensitivity reaction to the components of this investigational product
- Patients with respiratory and systemic infections requiring systemic antibiotic treatment
- Patients with clotting disorders or bleeding tendencies
- Patients with peptic ulcer at the time of screening
- Severe lung diseases that may affect the efficacy evaluation of this clinical trial at the discretion of the investigator
- For screening test results, creatinine clearance < 25 mL/min or AST, ALT more than 3 times the upper limit of normal
Show all 18Show fewer
- A person who have administered systemic corticosteroids or immunosuppressants within 4 weeks of the first administration of the investigational drug
- A person who have administered antiviral drugs, systemic/inhaled glucocorticosteroids within 48 hours of the first administration of investigational drugs
- A person who have administered mucolytics, sputum discharge agents, antitussives, herbal medicines with antitussive/ expectorant effects, and antihistamines within 48 hours of the first administration of investigational drugs
- A person who need or plan to take contraindicated drugs or therapies during this clinical trial period
- Patient with liver cirrhosis or cystathionine synthetase deficiency
- Patient who have clinically significant diseases and disorders in the cardiovascular system, endocrine system, and central nervous system at the time of screening, or who have a history of malignant tumors or mental disorders (eg. depression) (However, participation is possible if there is no recurrence for more than 5 years after surgery at the time of screening)
- A person with a history of alcoholism or drug abuse
- Heavy smokers (more than 15 cigarettes per day) within 4 weeks from the time of screening
- Pregnant or lactating
- Among female subjects of childbearing potential, women who do not intend to use appropriate contraceptive methods or plan to become pregnant during this clinical trial
- A person who administered other investigational drugs within 4 weeks from the time of screening
- A person who are not suitable for participation in this clinical trial under the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Active-control, Parallel Group, Randomized, Double-blinded, Non-inferiority Investigator Initiative Clinical Trial to Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule on Patients With Acute Bronchitis
The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
Read the detailed description
The purpose of this clinical trial is to evaluate the following in patients with acute bronchitis at the 7th day of administration of the investigational drug.
primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including sputum symptoms, of Bronpass tab. compared to Erdos capsule.
- Conditions
- Acute Bronchitis
- Being tested
- Bronpass Tab., Placebo of Erdos capsule, Erdos capsule, Placebo of Bronpass Tab.
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronpass Tab.Drug
Twice a day
Placebo of Erdos capsuleDrug
Three times a day (It is for the masking.)
Erdos capsuleDrug
Three times a day
Placebo of Bronpass Tab.Drug
Twice a day (It is for the masking.)
| Study group | Role | What they receive |
|---|---|---|
| Bronpass Tab. | Experimental | Not described Receives: Drug: Bronpass Tab.; Drug: Placebo of Erdos capsule |
| Erdos capsule | Active comparator | Not described Receives: Drug: Erdos capsule; Drug: Placebo of Bronpass Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BSS(Bronchitis severity score) total score
Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline
- The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.
Measured: Visit 3 (Day 7)
Secondary outcomes (8)
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline
- The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom.
Measured: Visit 3 (Day 7)
Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product
- The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom.
Measured: Visit 3 (Day 7)
Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug
- The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction.
Measured: Visit 3 (Day 7)
Number of rescue drug doses
Number of rescue drug doses at 7 days after administration of investigational drug
Measured: Visit 3 (Day 7)
Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Measured: Visit 3 (Day 7)
Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Measured: Visit 3 (Day 7)
Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Measured: Visit 3 (Day 7)
Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Measured: Visit 3 (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Apr 2022
- Primary completion28 Dec 2022
- Study completion16 May 2023
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.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang-Ha Yoo
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Sponsor-investigator, Kwang-Ha Yoo, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038084
- Sponsor's protocol ID
- HL-BRPS-501
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2023
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Active-control, Parallel Group, Randomized, Double-blinded, Non-inferiority Investigator Initiative Clinical Trial to Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule on Patients With Acute Bronchitis
- ClinicalTrials.gov ID
- NCT06038084
- Acronym / sponsor ID
- HL-BRPS-501
- Conditions
- Acute Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kwang-Ha YooUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 14 Sep 2023 (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.
The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
Detailed description
The purpose of this clinical trial is to evaluate the following in patients with acute bronchitis at the 7th day of administration of the investigational drug.
primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including sputum symptoms, of Bronpass tab. compared to Erdos capsule.
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., Drug: Placebo of Erdos capsule |
| Erdos capsule | Active comparator | Drug: Erdos capsule, Drug: Placebo of Bronpass Tab. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult aged 19 to 80 at the time of screening
- Patients with an acute bronchitis severity score (BSS) of 5 or higher at the time of screening and the first day of administration of the investigational drug
- Patients with symptoms of acute bronchitis within 48 hours from the time of screening
- Patients who voluntarily gave written consent to participate in this clinical trial
Key exclusion criteria (18 listed)
- Patients with a known hypersensitivity reaction to the components of this investigational product
- Patients with respiratory and systemic infections requiring systemic antibiotic treatment
- Patients with clotting disorders or bleeding tendencies
- Patients with peptic ulcer at the time of screening
- Severe lung diseases that may affect the efficacy evaluation of this clinical trial at the discretion of the investigator
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.Twice a day | Drug | Bronpass Tab. |
| Placebo of Erdos capsuleThree times a day (It is for the masking.) | Drug | Bronpass Tab. |
| Erdos capsuleThree times a day | Drug | Erdos capsule |
| Placebo of Bronpass Tab.Twice a day (It is for the masking.) | Drug | Erdos capsule |
Primary outcome
Change in BSS(Bronchitis severity score) total score
Time frame: Visit 3 (Day 7)
Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.
8 secondary outcomes
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
Time frame: Visit 3 (Day 7)
Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
Time frame: Visit 3 (Day 7)
Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
Time frame: Visit 3 (Day 7)
Number of rescue drug doses
Time frame: Visit 3 (Day 7)
Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
Time frame: Visit 3 (Day 7)
Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Time frame: Visit 3 (Day 7)
Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Time frame: Visit 3 (Day 7)
Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Time frame: Visit 3 (Day 7)
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 14 Sep 2023.
Related trials for Acute Bronchitis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
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 Bronpass Tab. and Erdos capsule in people with Acute Bronchitis, run by Kwang-Ha Yoo 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 4 inclusion and 18 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 14 Sep 2023. 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. 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 in BSS(Bronchitis severity score) total score (time frame: Visit 3 (Day 7)). 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 14 Sep 2023.