Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 3:41 AM
Study NCT ID:
NCT07111468
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 279}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchitis Severity Score(BSS)', 'timeFrame': 'Day 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Bronchitis']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants 19 years ≤ age ≤ 80 years\n* Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)\n* BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1\n* Patients who voluntarily signed the consent form\n\nExclusion Criteria:\n\n* Severe lung disease as determined by the investigator\n* Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis\n* Active infection requiring systemic antibiotic treatment\n* Patients who need to take contraindicated concomitant medications'}, 'identificationModule': {'nctId': 'NCT07111468', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis', 'orgStudyIdInfo': {'id': 'YHP2401-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YHP2401', 'interventionNames': ['Drug: YHP2401']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YHR2402', 'interventionNames': ['Drug: YHR2402']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YHR2403', 'interventionNames': ['Drug: YHR2403']}], 'interventions': [{'name': 'YHP2401', 'type': 'DRUG', 'description': 'Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403)', 'armGroupLabels': ['YHP2401']}, {'name': 'YHR2402', 'type': 'DRUG', 'description': 'Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403)', 'armGroupLabels': ['YHR2402']}, {'name': 'YHR2403', 'type': 'DRUG', 'description': 'Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403)', 'armGroupLabels': ['YHR2403']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14584', 'city': 'Bucheon-si', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '24253', 'city': 'Chuncheon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Hallym University Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '54538', 'city': 'Iksan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'zip': '03181', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03312', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Eunpyeong St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05030', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05355', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '11765', 'city': 'Uijeongbu-si', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': '44033', 'city': 'Ulsan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Seunghui Son', 'role': 'CONTACT', 'email': 'clinicaltrials@yuhan.co.kr', 'phone': '82)2-828-0567'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}