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OpenTrials
Completed

NCT Number: NCT06688292

The Safety and Effectiveness of Taneasy and Actein in COPD Patients

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
  • Phenylketonuria (PKU).

Treatment and study plan

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.

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.

Other names: acetylcysteine effervesecent 600mg

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bun Yao Biotechnology Co., Ltd

Industry

Collaborators

  • KGS Pharmamate Co., Ltd
  • Taichung Veterans General Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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