Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-30 @ 10:57 PM
Study NCT ID:
NCT02972866
Status:
WITHDRAWN
Last Update Posted:
2019-10-09
First Post:
2016-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Regulatory strategy', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2016-11-11', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.', 'timeFrame': '28 days', 'description': 'The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.', 'detailedDescription': 'Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.\n\nThis study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 12.\n2. History of alergic persistent rhinitis moderate to severe at least 2 years.\n3. Proved alergic using PRICK or RAST test.\n4. Nasal symptoms (NIS) \\> 3 and nasal obstruction \\>1.\n5. Indication of nasal corticorteroids use..\n6. Washout of nasal corticorteroids for 14 days.\n7. ICF.\n\nExclusion Criteria:\n\n1. Other types of rhinitis;\n2. Asthma non controled\n3. Use of oral/injectable corticoids 30 days before screening.\n4. patients not eligible to complete diaries.\n5. patients with alergy to any substance of medicines.\n6. non controlled desease.'}, 'identificationModule': {'nctId': 'NCT02972866', 'acronym': 'RINEX32', 'briefTitle': 'Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eurofarma Laboratorios S.A.'}, 'officialTitle': 'Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe', 'orgStudyIdInfo': {'id': 'EF148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noex 32mcg', 'description': 'Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.\n\nTretament of 28 days.', 'interventionNames': ['Drug: Budesonide']}, {'type': 'EXPERIMENTAL', 'label': 'Budecort Aqua 32 mcg', 'description': 'Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.\n\nTretament of 28 days.', 'interventionNames': ['Drug: Budesonide']}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'otherNames': ['Noex 32mcg', 'Budecort Aqua 32mcg'], 'description': 'Suspention to nasal use, 2 atomization in each nostril during the morning and at night.', 'armGroupLabels': ['Budecort Aqua 32 mcg', 'Noex 32mcg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Allergisa pesquisa dermato-cosmética ltda', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Mauro Acir Crippa Junior', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergisa Pesquisa Dermato-Cosmética Ltda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "Undecided, but could be shared upon investigator's request."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurofarma Laboratorios S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}