The Safety and Effectiveness of Taneasy and Actein in COPD Patients

NCT06688292 | Completed Phase 4

• 1 other identifier: BCQ230209TC
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Taneasy 600mg granules

EXPERIMENTAL

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

Drug: Taneasy 600mg granules

Actein effervescent tablets 600MG

ACTIVE COMPARATOR

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

Drug: Actein effervescent 600mg

Interventions

Taneasy 600mg granules DRUG

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

Taneasy 600mg granules

Actein effervescent 600mg DRUG

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

Also known as: acetylcysteine effervesecent 600mg

Actein effervescent tablets 600MG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Phenylketonuria (PKU).

Sponsors & Collaborators

• Bun Yao Biotechnology Co., Ltd: lead
• KGS Pharmamate Co., Ltd: collaborator
• Taichung Veterans General Hospital, Taichung: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: September 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)