Acute BronchitisPhase 3NCT04260555
Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis
A Phase 3 study testing DW1601, DW16011 and DW16012 in people with Acute Bronchitis, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- DW1601, DW16011 and DW16012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2018to 28 Feb 2021
- 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 79 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 who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients with systemic infections requiring systemic antibiotic therapy
- patient with hemostatic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
- Conditions
- Acute Bronchitis
- Being tested
- DW1601, DW16011, DW16012
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1601Drug
Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
DW16011Drug
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
DW16012Drug
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)
| Study group | Role | What they receive |
|---|---|---|
| TEST | Experimental | tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml Receives: Drug: DW1601 |
| Reference 1 | Active comparator | tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml Receives: Drug: DW16011 |
| Reference 2 | Active comparator | tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml Receives: Drug: DW16012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchitis Severity Score(BSS)
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start20 Dec 2018
- Primary completion9 Dec 2019
- Study completion28 Feb 2021 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260555
- Sponsor's protocol ID
- DW1601-301
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 7 Feb 2020
- 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 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
- ClinicalTrials.gov ID
- NCT04260555
- Acronym / sponsor ID
- DW1601-301
- Conditions
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 7 Feb 2020 (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-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEST | Experimental | Drug: DW1601tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml |
| Reference 1 | Active comparator | Drug: DW16011tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml |
| Reference 2 | Active comparator | Drug: DW16012tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml |
Who may qualify
- Ages
- 19 to 79 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 (3 listed)
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Patients with systemic infections requiring systemic antibiotic therapy
- patient with hemostatic disorder
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 |
|---|---|---|
| DW1601Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml) | Drug | TEST |
| DW16011Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml) | Drug | Reference 1 |
| DW16012Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml) | Drug | Reference 2 |
Primary outcome
Bronchitis Severity Score(BSS)
Time frame: Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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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 DW1601, DW16011 and DW16012 in people with Acute Bronchitis, run by Daewon Pharmaceutical 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 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: status not confirmed, as of the sponsor's last update on 7 Feb 2020. 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?
Results are not available in the source record.
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(BSS) (time frame: Day 4). 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 7 Feb 2020.