Acute BronchitisPhase 3NCT07093697
A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212
A Phase 3 study testing DW5121, DW51211 and DW51212 in people with Acute Bronchitis, run by Daewon Pharmaceutical Co., Ltd. at 8 sites in South Korea.
Trial summary
This is a Phase 3, randomized, double-blind, active-controlled, parallel-group, multi-center clinical trial to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with 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?
- DW5121, DW51211 and DW51212
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 28 Mar 2024to 27 May 2025
- 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
- Subjects must meet all of the following criteria to be eligible for the study:
- Male or female aged ≥19 years and <80 years at the time of informed consent.
- Patients diagnosed with acute bronchitis with productive cough symptoms within 48 hours prior to randomization (diagnosis based on clinical symptoms and chest X-ray; additional bacterial or viral testing may be performed if necessary).
- Subjects with a total Bronchitis Severity Score (BSS) of ≥5 and a sputum score of at least 1 at the randomization visit.
- Subjects who voluntarily provided written informed consent to participate in this clinical trial.
Who cannot join
- Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
- 1. History of hypersensitivity to any component of the investigational product or to drugs of a similar class.
- 2. Presence of any of the following medical histories or past surgical/interventional histories:
- Active infections requiring systemic antibiotic therapy
- Severe pulmonary diseases as determined by the investigator (e.g., bronchiectasis, bronchogenic carcinoma, interstitial lung disease, pneumonia, active tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease, asthma, chronic bronchitis, emphysema, etc.) or clinically significant abnormal findings on chest X-ray
- Obstructive sleep apnea syndrome
Show all 39Show fewer
- Glaucoma or elevated intraocular pressure
- Lower urinary tract obstruction (e.g., benign prostatic hyperplasia) or voiding dysfunction
- Hemorrhagic diathesis or bleeding tendency
- Hepatic dysfunction (ALT or AST > 3 × upper limit of normal)
- Renal impairment (glomerular filtration rate < 30 mL/min)
- eGFR (mL/min/1.73m²) = 175 × (serum creatinine)^(-1.154) × (age)^(-0.203) × 0.742 (if female)
- Uncontrolled thyroid dysfunction (TSH ≥ 1.5 × ULN)
- Uncontrolled diabetes mellitus (HbA1c > 9.0%)
- Uncontrolled hypertension (systolic or diastolic blood pressure ≥ 160/100 mmHg)
- Significant cardiovascular diseases as determined by the investigator (e.g., heart failure of NYHA class III/IV, atherosclerosis, pulmonary hypertension, peripheral artery disease) or QTc interval > 450 msec or other clinically significant ECG abnormalities
- Active peptic ulcer, gastrointestinal bleeding, or pyloroduodenal obstruction
- Central nervous system diseases such as epilepsy
- Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- History of malignancy except in the following cases:
- Disease-free for at least 5 years following completion of cancer treatment
- Subjects who have completed curative resection of basal cell carcinoma or squamous cell carcinoma of the skin, curative surgery for papillary thyroid carcinoma, or successful treatment of cervical carcinoma in situ at least 3 years prior to screening
- 3. Subjects expected to require any of the following medications during the clinical trial:
- Antibiotics, antivirals, systemic/inhaled glucocorticosteroids
- ACE inhibitors or ARBs (Note: Subjects on long-term stable doses of ACEIs or ARBs may be included)
- Mucolytics, expectorants, antitussives, herbal medicines with antitussive/expectorant effects
- Leukotriene receptor antagonists, antihistamines, β2 agonists, anticholinergic bronchodilators, CNS stimulants
- Coumarin-type anticoagulants (e.g., warfarin)
- Symptomatic treatments for acute bronchitis, analgesics (Note: Acetaminophen up to 1.5 g/day taken ≥24 hours before efficacy assessments is permitted)
- Sedatives
- Central nervous system depressants
- Phenytoin
- Monoamine oxidase (MAO) inhibitors administered within 2 weeks prior to the investigational product or expected to be used during the trial (e.g., antidepressants, antipsychotics, mood stabilizers, anti-Parkinson drugs)
- 4. Heavy smokers (≥15 cigarettes/day)
- For e-cigarettes, 10 puffs are considered equivalent to one conventional cigarette.
- 5. Pregnant or lactating women, or women who are unwilling to use appropriate contraception or who are planning to become pregnant during the study period.
- Acceptable contraceptive methods include hormonal contraception, intrauterine devices, sterilization of the partner (vasectomy or tubal ligation), or double-barrier methods (e.g., male condom with female diaphragm, sponge, or cervical cap).
- 6. Participation in another clinical trial and administration of an investigational drug or device within 4 weeks prior to screening
- 7. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this clinical trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
Yeungnam University Medical Center
Daegu, 42415
Wonkwang University Hospital
Iksan, 54538
Kangbuk Samsung Hospital
Seoul, 03181
Konkuk University Medical Center
Seoul, 05030
Hallym University Kangdong Sacred Heart Hospital
Seoul, 05355
Korea University Guro Hospital
Seoul, 08308
About this study
Official title: Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212
This is a Phase 3, randomized, double-blind, active-controlled, parallel-group, multi-center clinical trial to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of DW5121 over DW51211 and DW51212 by comparing the change in total Bronchitis Severity Score (BSS) at Day 4 after administration. Approximately equal numbers of patients were randomized in a 1:1:1 ratio to receive DW5121, DW51211, or DW51212 for 7 days. Efficacy and safety assessments were conducted at Day 4 and Day 7, with a follow-up contact approximately 5 days after the end of treatment to monitor adverse events.
Read the detailed description
Acute bronchitis is a common respiratory condition characterized by inflammation of the bronchial tubes, leading to symptoms such as coughing, sputum production, and discomfort. Effective treatment options with improved symptom control and safety profiles are needed.
This Phase 3, randomized, double-blind, parallel-group, multi-center, active-controlled, superiority trial aims to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. Eligible participants were randomized in a 1:1:1 ratio to receive either DW5121, DW51211, or DW51212 for 7 days.
The primary objective is to assess the change in total Bronchitis Severity Score (BSS) at Day 4 (±1 day) after drug administration, and to demonstrate the superiority of DW5121 compared to both comparators.
The secondary objectives include:
- Comparison of BSS score changes at Day 4 between DW5121 and each comparator, including statistical significance.
- Evaluation of overall efficacy and safety of DW5121 relative to DW51211 and DW51212.
Participants visited the study site at baseline, Day 4 (Visit 3), and Day 7 (Visit 4). A follow-up safety check (Visit 5) was conducted approximately 5 days after the last visit. Additional site visits or assessments were performed as necessary based on investigator's discretion to monitor adverse events.
This study provides important data on the potential benefits of DW5121 in managing symptoms of acute bronchitis, with an emphasis on both clinical efficacy and patient safety.
- Conditions
- Acute Bronchitis
- Being tested
- DW5121, DW51211, DW51212
- Keywords
- Acute bronchitis, Bronchitis Severity Score, respiratory infection, Phase 3 clinical trial
- Medical subject headings
- Bronchitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW5121Drug
Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days
DW51211Drug
Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days
DW51212Drug
Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days
| Study group | Role | What they receive |
|---|---|---|
| DW5121 Group | Experimental | Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days Receives: Drug: DW5121 |
| DW51211 Control Group | Active comparator | Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days Receives: Drug: DW51211 |
| DW51212 Control Group | Active comparator | Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days Receives: Drug: DW51212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 4 after dosing
The primary efficacy endpoint is the change from baseline in total BSS score at Day 4 after administration of DW5121 compared to DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms) where higher scores indicate a worse outcome (more severe bronchitis symptoms).
Measured: Day 4 after first dose
Secondary outcomes (7)
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 7 after dosing
Change from baseline in total BSS score at Day 7 after administration of DW5121 compared to DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms), where higher scores indicate a worse outcome (more severe bronchitis symptoms).
Measured: Day 7 after first dose
Change from baseline in Bronchitis Severity Score (BSS) symptom scores at Days 4 and 7 after dosing
Changes from baseline in individual BSS symptom scores at Days 4 and 7 after administration of DW5121 compared to DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms), where higher scores indicate a worse outcome (more severe bronchitis symptoms).
Measured: Days 4 and 7 after first dose
Response rate at Days 4 and 7 after dosing
Response defined as total BSS score ≤3 or a decrease of ≥7 points from baseline at Days 4 and 7 after dosing.
Measured: Days 4 and 7 after first dose
Investigator and patient assessment of overall improvement using a 5-point scale at Days 4 and 7 after dosing
Overall improvement will be assessed separately by the investigator and the patient at Days 4 and 7 after dosing using a protocol-defined 5-point categorical scale. The scale consists of the following categories: 4 (cure), 3 (significant improvement), 2 (improvement), 1 (some improvement), 0 (non-improvement or worsening of symptoms). Higher scores indicate better improvement.
Measured: Days 4 and 7 after first dose
Treatment efficacy rate based on improvement at Days 4 and 7 after dosing
Treatment efficacy defined as "cure" or "significant improvement" based on investigator and patient assessment of overall improvement at Days 4 and 7 after dosing.
Measured: Days 4 and 7 after first dose
Patient satisfaction with treatment using a 5-point scale at Days 4 and 7 after dosing
Patient satisfaction with treatment will be assessed by the patient at Days 4 and 7 after dosing using a protocol-defined 5-point categorical scale. The scale consists of the following categories: 4 (very satisfied), 3 (satisfied), 2 (neutral), 1 (dissatisfied), 0 (very dissatisfied). Higher scores indicate better improvement.
Measured: Days 4 and 7 after first dose
Comparison of Bronchitis Severity Score (BSS) total score changes at Days 4 and 7 after dosing(DW51211 vs DW51212)
Comparison of change from baseline in total BSS score at Days 4 and 7 after administration of DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms), where higher scores indicate a worse outcome (more severe bronchitis symptoms).
Measured: Days 4 and 7 after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start28 Mar 2024
- Primary completion27 May 2025
- Study completion27 May 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaejeong Shim, Principal Investigator, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093697
- Sponsor's protocol ID
- DW5121-302
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212
- ClinicalTrials.gov ID
- NCT07093697
- Acronym / sponsor ID
- DW5121-302
- Conditions
- Acute Bronchitis
- Keywords
- Acute bronchitis, Bronchitis Severity Score, respiratory infection, Phase 3 clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 30 Jul 2025 (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.
This is a Phase 3, randomized, double-blind, active-controlled, parallel-group, multi-center clinical trial to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of DW5121 over DW51211 and DW51212 by comparing the change in total Bronchitis Severity Score (BSS) at Day 4 after administration. Approximately equal numbers of patients were randomized in a 1:1:1 ratio to receive DW5121, DW51211, or DW51212 for 7 days. Efficacy and safety assessments were conducted at Day 4 and Day 7, with a follow-up contact approximately 5 days after the end of treatment to monitor adverse events.
Detailed description
Acute bronchitis is a common respiratory condition characterized by inflammation of the bronchial tubes, leading to symptoms such as coughing, sputum production, and discomfort. Effective treatment options with improved symptom control and safety profiles are needed.
This Phase 3, randomized, double-blind, parallel-group, multi-center, active-controlled, superiority trial aims to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. Eligible participants were randomized in a 1:1:1 ratio to receive either DW5121, DW51211, or DW51212 for 7 days.
The primary objective is to assess the change in total Bronchitis Severity Score (BSS) at Day 4 (±1 day) after drug administration, and to demonstrate the superiority of DW5121 compared to both comparators.
The secondary objectives include:
- Comparison of BSS score changes at Day 4 between DW5121 and each comparator, including statistical significance.
- Evaluation of overall efficacy and safety of DW5121 relative to DW51211 and DW51212.
Participants visited the study site at baseline, Day 4 (Visit 3), and Day 7 (Visit 4). A follow-up safety check (Visit 5) was conducted approximately 5 days after the last visit. Additional site visits or assessments were performed as necessary based on investigator's discretion to monitor adverse events.
This study provides important data on the potential benefits of DW5121 in managing symptoms of acute bronchitis, with an emphasis on both clinical efficacy and patient safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DW5121 Group | Experimental | Drug: DW5121Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days |
| DW51211 Control Group | Active comparator | Drug: DW51211Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days |
| DW51212 Control Group | Active comparator | Drug: DW51212Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥19 years and <80 years at the time of informed consent.
- Patients diagnosed with acute bronchitis with productive cough symptoms within 48 hours prior to randomization (diagnosis based on clinical symptoms and chest X-ray; additional bacterial or viral testing may be performed if necessary).
- Subjects with a total Bronchitis Severity Score (BSS) of ≥5 and a sputum score of at least 1 at the randomization visit.
- Subjects who voluntarily provided written informed consent to participate in this clinical trial.
Key exclusion criteria (39 listed)
- Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
- 1. History of hypersensitivity to any component of the investigational product or to drugs of a similar class.
- 2. Presence of any of the following medical histories or past surgical/interventional histories:
- Active infections requiring systemic antibiotic therapy
- Severe pulmonary diseases as determined by the investigator (e.g., bronchiectasis, bronchogenic carcinoma, interstitial lung disease, pneumonia, active tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease, asthma, chronic bronchitis, emphysema, etc.) or clinically significant abnormal findings on chest X-ray
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 |
|---|---|---|
| DW5121Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days | Drug | DW5121 Group |
| DW51211Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days | Drug | DW51211 Control Group |
| DW51212Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days | Drug | DW51212 Control Group |
Primary outcome
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 4 after dosing
Time frame: Day 4 after first dose
The primary efficacy endpoint is the change from baseline in total BSS score at Day 4 after administration of DW5121 compared to DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms) where higher scores indicate a worse outcome (more severe bronchitis symptoms).
7 secondary outcomes
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 7 after dosing
Time frame: Day 7 after first dose
Change from baseline in Bronchitis Severity Score (BSS) symptom scores at Days 4 and 7 after dosing
Time frame: Days 4 and 7 after first dose
Response rate at Days 4 and 7 after dosing
Time frame: Days 4 and 7 after first dose
Investigator and patient assessment of overall improvement using a 5-point scale at Days 4 and 7 after dosing
Time frame: Days 4 and 7 after first dose
Treatment efficacy rate based on improvement at Days 4 and 7 after dosing
Time frame: Days 4 and 7 after first dose
Patient satisfaction with treatment using a 5-point scale at Days 4 and 7 after dosing
Time frame: Days 4 and 7 after first dose
Comparison of Bronchitis Severity Score (BSS) total score changes at Days 4 and 7 after dosing(DW51211 vs DW51212)
Time frame: Days 4 and 7 after first dose
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 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Jaejeong Shim, Principal Investigator principal investigator
Korea University Guro Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DW5121, DW51211 and DW51212 in people with Acute Bronchitis, run by Daewon Pharmaceutical Co., Ltd. at 8 sites 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 39 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 4 after dosing (time frame: Day 4 after first dose). 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 30 Jul 2025.