Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
Study NCT ID:
NCT06688292
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2024-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of Taneasy and Actein in COPD Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', '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 Actein effervescent tablets 600MG 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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged older than 20\\~75 years old.\n2. Able to sign informed consent prior to the study.\n3. Subjects have COPD.\n\nExclusion Criteria:\n\n1. Subjects with known hypersensitivity to Acetylcysteine preparations.\n2. 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.)\n3. Pregnancy or breast-feeding woman.\n4. Female subjects or their sexual partners do not use contraception during the trial.\n5. Joining any drug clinical trial within 3 months prior to dosing.\n6. Investigator considered to be inappropriate for enrollment.\n7. Phenylketonuria (PKU).'}, 'identificationModule': {'nctId': 'NCT06688292', 'briefTitle': 'The Safety and Effectiveness of Taneasy and Actein in COPD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bun Yao Biotechnology Co., Ltd'}, 'officialTitle': 'A Randomized, Safety and Efficacy Study of Taneasy 600mg Granules and Actein Effervescent Tablets 600MG in COPD Subjects', 'orgStudyIdInfo': {'id': 'BCQ230209TC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taneasy 600mg granules', 'description': 'Dose： 600 mg/time. Use ：two times per day.', 'interventionNames': ['Drug: Taneasy 600mg granules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Actein effervescent tablets 600MG', 'description': 'Dose： 600 mg/time. Use ：two times per day', 'interventionNames': ['Drug: Actein effervescent 600mg']}], '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.', 'armGroupLabels': ['Taneasy 600mg granules']}, {'name': 'Actein effervescent 600mg', 'type': 'DRUG', 'otherNames': ['acetylcysteine effervesecent 600mg'], 'description': 'Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis.', 'armGroupLabels': ['Actein effervescent tablets 600MG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bun Yao Biotechnology Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KGS Pharmamate Co., Ltd', 'class': 'UNKNOWN'}, {'name': 'Taichung Veterans General Hospital, Taichung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}