Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT03323866
Status:
TERMINATED
Last Update Posted:
2022-09-21
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mometasone vs Budesonide in CRS With Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D009298', 'term': 'Nasal Polyps'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Difficulty with recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease specific quality of life questionnaire', 'timeFrame': '3 months after beginning of treatment', 'description': 'SinoNasal Outcome Test - 22 This is a symptom score ranging from 0 to 110 points, 0 representing the absence of nasal symptoms and 110 being the most severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Endoscopic evaluation of the nasal cavities', 'timeFrame': '3 months after beginning of treatment', 'description': 'Lund Kennedy Endoscopic Score This is a score evaluating the healing of sinonasal cavities from 0 point (normal and healthy looking cavity) to 20 points (the most diseased cavity).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis']}, 'descriptionModule': {'briefSummary': 'The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic rhinosinusitis with nasal polyps\n* Absence of active infection at start of study\n\nExclusion Criteria:\n\n* Diagnosis of chronic rhinosinusitis without nasal polyps\n* Diagnosis of recurrent acute bacterial rhinosinusitis\n* Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)\n* Cystic fibrosis or ciliary dyskinesia\n* Allergy to corticosteroids\n* Pregnant or lactating women\n* Contra-indication to intranasal steroids'}, 'identificationModule': {'nctId': 'NCT03323866', 'briefTitle': 'Mometasone vs Budesonide in CRS With Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis', 'orgStudyIdInfo': {'id': '2017-1569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone nasal spray', 'description': 'Mometasone nasal spray 50 mcg/dose, 2 sprays/nostril twice daily x 3 months Patients will also be taking Sinus Rinse once daily throughout the study period', 'interventionNames': ['Drug: Mometasone nasal spray']}, {'type': 'EXPERIMENTAL', 'label': 'Budesonide irrigation', 'description': '2 cc budesonide nebule (0,5 mg/cc) incorporated to 240 of saline water (Sinus Rinse) to be taken on a daily basis x 3 months', 'interventionNames': ['Drug: Budesonide 0.5 MG/ML']}], 'interventions': [{'name': 'Budesonide 0.5 MG/ML', 'type': 'DRUG', 'description': '2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily', 'armGroupLabels': ['Budesonide irrigation']}, {'name': 'Mometasone nasal spray', 'type': 'DRUG', 'description': 'Mometasone 50 mcg/spray 2 sprays twice daily', 'armGroupLabels': ['Mometasone nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Otolaryngologist', 'investigatorFullName': 'Marie Bussières', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}