The Safety and Effectiveness of Taneasy and Actein in COPD Patients

Bun Yao Biotechnology Co., Ltd

Status and phase: Invitation-only; Phase 4

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Drug: Actein effervescent 600mg; Drug: Taneasy 600mg granules

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06688292

BCQ230209TC

Details and patient eligibility

About

To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG 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

1. Subjects aged older than 20~75 years old.
2. Able to sign informed consent prior to the study.
3. Subjects have COPD.

Exclusion criteria

1. Subjects with known hypersensitivity to Acetylcysteine preparations.
2. 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.)
3. Pregnancy or breast-feeding woman.
4. Female subjects or their sexual partners do not use contraception during the trial.
5. Joining any drug clinical trial within 3 months prior to dosing.
6. Investigator considered to be inappropriate for enrollment.
7. Phenylketonuria (PKU).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Taneasy 600mg granules

Experimental group

Description:

Dose： 600 mg/time. Use ：two times per day.

Treatment:

Drug: Taneasy 600mg granules

Actein effervescent tablets 600MG

Active Comparator group

Description:

Dose： 600 mg/time. Use ：two times per day

Treatment:

Drug: Actein effervescent 600mg