Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06828120
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'one month', 'description': 'Primary Evaluation Criteria:\n\nCAT 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study will enroll 40\\~60 patients and complete 40 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged older than 20\\~75 years old.\n* Able to sign informed consent prior to the study.\n* The appearance of sputum and the difficulty of expectoration are both at level 2 or above.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity to Acetylcysteine preparations.\n* 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.)\n* Pregnancy or breast-feeding woman.\n* Female subjects or their sexual partners do not use contraception during the trial.\n* Joining any drug clinical trial within 3 months prior to dosing.\n* Investigator considered to be inappropriate for enrollment.'}, 'identificationModule': {'nctId': 'NCT06828120', 'briefTitle': 'A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bun Yao Biotechnology Co., Ltd'}, 'officialTitle': 'A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Fluimucil 600mg Granules in COPD Subjects', 'orgStudyIdInfo': {'id': 'BCQ230209TP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taneasy 600mg granules', 'description': 'Dose： 600 mg/time. Use ：two times per day.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluimucil 600mg granules', 'description': 'Dose： 600 mg/time. Use ：two times per day'}], 'interventions': [{'name': 'Taneasy 600mg granules', 'type': 'DRUG', 'description': 'Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.'}, {'name': 'Fluimucil 600mg granules', 'type': 'DRUG', 'description': 'Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bun Yao Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinny biotech limited', 'class': 'UNKNOWN'}, {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}