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

NCT06828120 | Completed Phase 4

• 1 other identifier: BCQ230209TP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Fluimucil 600mg granules

ACTIVE COMPARATOR

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

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.

Fluimucil 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.

Eligibility Criteria

• Age: 20 Years - 75 Years
• 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.
• The appearance of sputum and the difficulty of expectoration are both at level 2 or above.

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.

Sponsors & Collaborators

• Bun Yao Biotechnology Co., Ltd: lead
• Clinny biotech limited: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

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: February 10, 2025
• First Posted: February 14, 2025
• Study Start: February 20, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 17, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)