COPD (Chronic Obstructive Pulmonary Disease)Phase 4NCT06828120
A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects
A Phase 4 study testing Taneasy 600mg granules and Fluimucil 600mg granules in people with COPD (Chronic Obstructive Pulmonary Disease), run by Bun Yao Biotechnology Co., Ltd at 1 site in Taiwan.
Trial summary
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600mg granules administered twice daily for 14 days in treatment of COPD Disease. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Taneasy 600mg granules and Fluimucil 600mg granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2025to 17 Sep 2025
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged older than 20~75 years old.
- Able to sign informed consent prior to the study.
- The appearance of sputum and the difficulty of expectoration are both at level 2 or above.
Who cannot join
- Subjects with known hypersensitivity to Acetylcysteine preparations.
- Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
- Pregnancy or breast-feeding woman.
- Female subjects or their sexual partners do not use contraception during the trial.
- Joining any drug clinical trial within 3 months prior to dosing.
- Investigator considered to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600mg granules administered twice daily for 14 days in treatment of COPD Disease.
Read the detailed description
The study will enroll 40~60 patients and complete 40 patients.
- Being tested
- Taneasy 600mg granules, Fluimucil 600mg granules
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taneasy 600mg granulesDrug
Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.
Fluimucil 600mg granulesDrug
Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.
| Study group | Role | What they receive |
|---|---|---|
| Taneasy 600mg granules | Experimental | Dose： 600 mg/time. Use ：two times per day. |
| Fluimucil 600mg granules | Active comparator | Dose： 600 mg/time. Use ：two times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600MG granules administered twice daily for 14 days in treatment of COPD Disease.
Primary Evaluation Criteria:
CAT score (COPD Assessment Test) The maximum score is 40. Higher scores indicate your COPD has a greater impact on your overall health and well-being.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Feb 2025
- Primary completion3 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bun Yao Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinny biotech limited, Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828120
- Sponsor's protocol ID
- BCQ230209TP
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2025
- Last updated
- 18 Sep 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects
- ClinicalTrials.gov ID
- NCT06828120
- Acronym / sponsor ID
- BCQ230209TP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bun Yao Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Clinny biotech limited, Taipei Veterans General Hospital, Taiwan
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 14 Feb 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.
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600mg granules administered twice daily for 14 days in treatment of COPD Disease.
Detailed description
The study will enroll 40~60 patients and complete 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taneasy 600mg granules | Experimental | –Dose： 600 mg/time. Use ：two times per day. |
| Fluimucil 600mg granules | Active comparator | –Dose： 600 mg/time. Use ：two times per day |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged older than 20~75 years old.
- Able to sign informed consent prior to the study.
- The appearance of sputum and the difficulty of expectoration are both at level 2 or above.
Key exclusion criteria (6 listed)
- Subjects with known hypersensitivity to Acetylcysteine preparations.
- Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
- Pregnancy or breast-feeding woman.
- Female subjects or their sexual partners do not use contraception during the trial.
- Joining any drug clinical trial within 3 months prior to dosing.
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 |
|---|---|---|
| Taneasy 600mg granulesTreatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis. | Drug | – |
| Fluimucil 600mg granulesTreatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis. | Drug | – |
Primary outcome
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600MG granules administered twice daily for 14 days in treatment of COPD Disease.
Time frame: one month
Primary Evaluation Criteria: CAT score (COPD Assessment Test) The maximum score is 40. Higher scores indicate your COPD has a greater impact on your overall health and well-being.
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 18 Sep 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.
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 4 study testing Taneasy 600mg granules and Fluimucil 600mg granules in people with COPD (Chronic Obstructive Pulmonary Disease), run by Bun Yao Biotechnology Co., Ltd at 1 site in Taiwan.
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 6 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 18 Sep 2025. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate the safety and efficacy of Taneasy 600mg granules and Fluimucil 600MG granules administered twice daily for 14 days in treatment of COPD Disease. (time frame: one month). 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 18 Sep 2025.