Acute BronchitisPhase 2HL301NCT02250027
A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)
A Phase 2 study testing HL301 300mg capsule in people with Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis. BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Bronchitis, Acute Exacerbations of Chronic Bronchitis
- What is being tested?
- HL301 300mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Jul 2014
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender, 19 years ≤ age ≤ 80 years
- Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2
- Written consent voluntarily to participate in this clinical trial
Who cannot join
- Patients who were increased the bleeding tendency
- Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
- Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
- Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation
Show all 13Show fewer
- Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
- Patients with drug or alcohol abuse
- Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
- The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
- Pregnant or breast-feeding
- Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
- Patients who investigators determines not appropriate to take part in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis.
- BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum
- Being tested
- HL301 300mg capsule, Placebo
- Keywords
- acute bronchitis, acute exacerbations of chronic bronchitis
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL301 300mg capsuleDrug
Also called experimental A (0.6g/day) : HL301 300mg 2 capsule, experimental B (1.2g/day) : HL301 300mg 4 capsule, experimental C (1.8g/day) : HL301 300mg 6 capsule
2 capsules at once, 3 times a day, for 7 days
PlaceboDrug
Also called Microcrystalline Cellulose
2 capsules at once, 3 times a day, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| experimental A (0.6g/day) | Experimental | HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days Receives: Drug: HL301 300mg capsule; Drug: Placebo |
| experimental B (1.2g/day) | Experimental | HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days Receives: Drug: HL301 300mg capsule; Drug: Placebo |
| experimental C (1.8g/day) | Experimental | HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days Receives: Drug: HL301 300mg capsule |
| Placebo | Placebo comparator | placebo: 2 capsules at once, 3 times a day, for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchitis Severity Score
Bronchitis Severity Score
Measured: baseline(day 0) and day 7
Secondary outcomes (3)
Breathlessness, Cough, and Sputum Scale
Breathlessness, Cough, and Sputum Scale
Measured: baseline(day 0) and day 7
evaluation of symptoms of cough and sputum
Measured: baseline(day 0) and day 7
Total usage of acetaminophen
Measured: baseline(day 0) and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250027
- Sponsor's protocol ID
- HL_HL301_201
- Acronym
- HL301
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)
- ClinicalTrials.gov ID
- NCT02250027
- Acronym / sponsor ID
- HL301 / HL_HL301_201
- Keywords
- acute bronchitis, acute exacerbations of chronic bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Sep 2014 (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 purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis.
- BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experimental A (0.6g/day) | Experimental | Drug: HL301 300mg capsule, Drug: PlaceboHL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days |
| experimental B (1.2g/day) | Experimental | Drug: HL301 300mg capsule, Drug: PlaceboHL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days |
| experimental C (1.8g/day) | Experimental | Drug: HL301 300mg capsuleHL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo: 2 capsules at once, 3 times a day, for 7 days |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both gender, 19 years ≤ age ≤ 80 years
- Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2
- Written consent voluntarily to participate in this clinical trial
Key exclusion criteria (13 listed)
- Patients who were increased the bleeding tendency
- Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
- Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
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 |
|---|---|---|
| HL301 300mg capsuleAlso: experimental A (0.6g/day) : HL301 300mg 2 capsule, experimental B (1.2g/day) : HL301 300mg 4 capsule, experimental C (1.8g/day) : HL301 300mg 6 capsule2 capsules at once, 3 times a day, for 7 days | Drug | experimental A (0.6g/day), experimental B (1.2g/day), experimental C (1.8g/day) |
| PlaceboAlso: Microcrystalline Cellulose2 capsules at once, 3 times a day, for 7 days | Drug | Placebo, experimental A (0.6g/day), experimental B (1.2g/day) |
Primary outcome
Bronchitis Severity Score
Time frame: baseline(day 0) and day 7
Bronchitis Severity Score
3 secondary outcomes
Breathlessness, Cough, and Sputum Scale
Time frame: baseline(day 0) and day 7
evaluation of symptoms of cough and sputum
Time frame: baseline(day 0) and day 7
Total usage of acetaminophen
Time frame: baseline(day 0) and 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 26 Sep 2014.
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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 2 study testing HL301 300mg capsule in people with Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, 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 3 inclusion and 13 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 2014. 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?
Bronchitis Severity Score (time frame: baseline(day 0) and 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 26 Sep 2014.