Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:58 AM
Study NCT ID:
NCT07316959
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Long-Term Low Dose Macrolide Therapy in Preventing Early Recurrence of Nasal Polyps After Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-03', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in symptom and disease severity scores', 'timeFrame': '3 months', 'description': '(Change in Sinonasal Outcome Test-22 (SNOT-22) , Lund-Kennedy score, and Lund-Mackay score) from baseline to 12 weeks after endoscopic sinus surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['macrolides', 'Chronic Rhinosinusitis'], 'conditions': ['Chronic Rhinosinusitis With Nasal Polyps']}, 'referencesModule': {'references': [{'pmid': '10887619', 'type': 'RESULT', 'citation': 'Yamada T, Fujieda S, Mori S, Yamamoto H, Saito H. Macrolide treatment decreased the size of nasal polyps and IL-8 levels in nasal lavage. Am J Rhinol. 2000 May-Jun;14(3):143-8. doi: 10.2500/105065800782102717.'}], 'seeAlsoLinks': [{'url': 'https://pesquisa.bvsalud.org/portal/resource/pt/wpr-172313', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluated the effectiveness of long-term, low-dose clarithromycin (250 mg/day) in reducing symptoms, improving endoscopic and radiologic scores, and preventing early recurrence of nasal polyps after endoscopic sinus surgery. Conducted at the ENT Department of Sir Ganga Ram Hospital, Lahore, the study included patients aged 15-75 undergoing surgery for nasal polyps. Group A received clarithromycin for three months in addition to standard therapy, while Group B received standard therapy alone. Patients treated with clarithromycin showed significantly greater improvements in SNOT, Lund-Kennedy, and Lund-Mackay scores at 8 and 12 weeks compared to controls (p\\<0.05). Polyp recurrence at three months was also lower in the macrolide group (12%) than in the non-macrolide group (32%).\n\nOverall, low-dose clarithromycin was found to be safe and effective in enhancing postoperative outcomes and reducing early recurrence of nasal polyps after endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nMale and female patients aged 15 to 75 years\n\nClinical diagnosis of nasal polyps\n\nUnderwent endoscopic sinus surgery\n\nWilling and able to provide informed consent Exclusion Criteria\n\nCurrent or recent use of antibiotics or macrolide therapy\n\nHistory of multiple facial fractures\n\nPresence of neurological disorders\n\nPresence of psychiatric or psychological disorders'}, 'identificationModule': {'nctId': 'NCT07316959', 'briefTitle': 'Efficacy of Long-Term Low Dose Macrolide Therapy in Preventing Early Recurrence of Nasal Polyps After Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Jinnah Medical University'}, 'officialTitle': 'Efficacy Of Long-Term Low Dose Macrolide Therapy In Preventing Early Recurrence Of Nasal Polyps After Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': '260/proposal-ENT/ERC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription', 'interventionNames': ['Procedure: clarithromycin 250 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).', 'interventionNames': ['Procedure: clarithromycin 250 mg']}], 'interventions': [{'name': 'clarithromycin 250 mg', 'type': 'PROCEDURE', 'otherNames': ['group B'], 'description': 'Following surgery, patients were split into two groups at random . For three months, patients in group A received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription drugs.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54780', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Muhammad Shouzib Sultan', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Jinnah Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}