COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Brief 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.
Detailed description
The study will enroll 40\ 60 patients and complete 40 patients.
Interventions
Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.
DRUGFluimucil 600mg granules
Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.
Sponsors
Clinny biotech limited
Taipei Veterans General Hospital, Taiwan
Bun Yao Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Taiwan
Outcome results
None listed