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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-09-17

Brief Summary

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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.

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Detailed Description

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

Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Taneasy 600mg granules

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

Group Type EXPERIMENTAL

No interventions assigned to this group

Fluimucil 600mg granules

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

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

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Taneasy 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.

Intervention Type DRUG

Fluimucil 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No