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

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.

Study Overview

• Status: Completed
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: Taneasy 600mg granules; Drug: Actein effervescent 600mg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taneasy 600mg granules; Dose： 600 mg/time. Use ：two times per day.	Drug: 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.
Active Comparator: Actein effervescent tablets 600MG; Dose： 600 mg/time. Use ：two times per day	Drug: Actein 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.; Other Names: acetylcysteine effervesecent 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	one month

Collaborators and Investigators

• Sponsor: Bun Yao Biotechnology Co., Ltd
• Collaborators: KGS Pharmamate Co., Ltd; Taichung Veterans General Hospital, Taichung

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Antioxidants; Protective Agents; Expectorants; Respiratory System Agents; Free Radical Scavengers; Acetylcysteine
• Other Study ID Numbers: BCQ230209TC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No