A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects

Bun Yao Biotechnology Co., Ltd

Status and phase

Not yet enrolling

Phase 4

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Treatments

Drug: Fluimucil 600mg granules

Drug: Taneasy 600mg granules

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06828120

BCQ230209TP

Details and patient eligibility

About

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.

Full description

The study will enroll 40~60 patients and complete 40 patients.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.