The Safety and Effectiveness of Taneasy and Actein in COPD Patients

A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Actein Effervescent Tablets 600MG in COPD Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06688292

Enrollment

Registered

2024-11-14

Start date

2024-09-20

Completion date

2024-12-31

Last updated

2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Brief summary

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.

Detailed description

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

Interventions

DRUGTaneasy 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.

DRUGActein effervescent 600mg

Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026