Acute BronchitisPhase 3NCT03654196
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients
A Phase 3 study testing HL301(Experimental) and Umkamin(Active Comparator) in people with Acute Bronchitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject 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?
- HL301(Experimental) and Umkamin(Active Comparator)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2018to 21 Sep 2018
- Phase
- Phase 3
- 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
- (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
- Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
- Those who can comply with the requirements of clinical trials
- Written consent voluntarily to participate in this clinical trial
Who cannot join
- Patients with respiratory and systemic infections requiring systemic antibiotic therapy
- Patients with bleeding tendency
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
- Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, 130-872
About this study
Official title: A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients
A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject
- Conditions
- Acute Bronchitis
- Being tested
- HL301(Experimental), Umkamin(Active Comparator)
- Keywords
- Acute 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(Experimental)Drug
Also called HL301 and Placebo of Umkamin
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
Umkamin(Active Comparator)Drug
Also called Placebo of HL301 and Umkamin
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
| Study group | Role | What they receive |
|---|---|---|
| HL301(Experimental) | Experimental | Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] Receives: Drug: HL301(Experimental) |
| Umkamin(Active Comparator) | Active comparator | Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] Receives: Drug: Umkamin(Active Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchitis Severity Total Score(BSS) Change
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
Measured: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary outcomes (2)
The improvement and improvement rate of the tester for the treatment
Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery
Measured: Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied
Measured: Visit 3 (7 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Mar 2018
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 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
- NCT03654196
- Sponsor's protocol ID
- HL_HL301_301
- Status last verified
- Feb 2019
- First submitted
- 29 Aug 2018
- Last updated
- 12 Feb 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 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients
- ClinicalTrials.gov ID
- NCT03654196
- Acronym / sponsor ID
- HL_HL301_301
- Conditions
- Acute Bronchitis
- Keywords
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 31 Aug 2018 (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.
A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL301(Experimental) | Experimental | Drug: HL301(Experimental)Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] |
| Umkamin(Active Comparator) | Active comparator | Drug: Umkamin(Active Comparator)Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both gender, 19 years ≤ age ≤ 80 years
- (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
- Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
- Those who can comply with the requirements of clinical trials
- Written consent voluntarily to participate in this clinical trial
Key exclusion criteria (5 listed)
- Patients with respiratory and systemic infections requiring systemic antibiotic therapy
- Patients with bleeding tendency
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
- Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
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(Experimental)Also: HL301 and Placebo of UmkaminTotal 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] | Drug | HL301(Experimental) |
| Umkamin(Active Comparator)Also: Placebo of HL301 and UmkaminTotal 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] | Drug | Umkamin(Active Comparator) |
Primary outcome
Bronchitis Severity Total Score(BSS) Change
Time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
2 secondary outcomes
The improvement and improvement rate of the tester for the treatment
Time frame: Visit 3 (7 day)
The satisfaction of the subject (Questionnaire)
Time frame: Visit 3 (7 day)
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 12 Feb 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 3 study testing HL301(Experimental) and Umkamin(Active Comparator) in people with Acute 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 5 inclusion and 5 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 12 Feb 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Total Score(BSS) Change (time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)). 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 12 Feb 2019.