Acute BronchitisPhase 3NCT05344638
A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
A Phase 3 study testing AGS (Experimental) and AGU (Active Comparator) in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- AGS (Experimental) and AGU (Active Comparator)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2019to 29 Jul 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both gender, 19 years ≤ age ≤ 75 years
- BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
- Patients without fever 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 or coagulation disorder
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
- In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
- Conditions
- Acute Bronchitis
- Being tested
- AGS (Experimental), AGU (Active Comparator)
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS (Experimental)Drug
tid
AGU (Active Comparator)Drug
tid
| Study group | Role | What they receive |
|---|---|---|
| AGS (Experimental) | Experimental | AGS + Placebo of AGU Receives: Drug: AGS (Experimental) |
| AGU (Active Comparator) | Active comparator | Placebo of AGS + AGU Receives: Drug: AGU (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 of Visit 3 compared to Visit 2
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point 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 (4)
Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2
Measured: 7days
Treatment response rate at Visit 3
Measured: 7days
Integrative Medicine Outcome Scale (IMOS)
Measured: 7days
Integrative Medicine Patient Satisfaction Scale (IMPSS)
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start17 Oct 2019
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
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, Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344638
- Sponsor's protocol ID
- AG1904
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2022
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
- ClinicalTrials.gov ID
- NCT05344638
- Acronym / sponsor ID
- AG1904
- Conditions
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 25 Apr 2022 (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, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGS (Experimental) | Experimental | Drug: AGS (Experimental)AGS + Placebo of AGU |
| AGU (Active Comparator) | Active comparator | Drug: AGU (Active Comparator)Placebo of AGS + AGU |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both gender, 19 years ≤ age ≤ 75 years
- BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
- Patients without fever 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 or coagulation disorder
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
- In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
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 |
|---|---|---|
| AGS (Experimental)tid | Drug | AGS (Experimental) |
| AGU (Active Comparator)tid | Drug | AGU (Active Comparator) |
Primary outcome
Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
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/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
4 secondary outcomes
Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2
Time frame: 7days
Treatment response rate at Visit 3
Time frame: 7days
Integrative Medicine Outcome Scale (IMOS)
Time frame: 7days
Integrative Medicine Patient Satisfaction Scale (IMPSS)
Time frame: 7days
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 25 Apr 2022.
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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 AGS (Experimental) and AGU (Active Comparator) in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals 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 25 Apr 2022. 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 of Visit 3 compared to Visit 2 (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 25 Apr 2022.