Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02541760
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2015-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-02', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response', 'timeFrame': '1 months', 'description': 'Defined as complete, partial, or no response based on the physician examination'}], 'secondaryOutcomes': [{'measure': 'Drug side effects', 'timeFrame': '1 month', 'description': 'Frequency of Drug side effects as reported by the children or their parents'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Otitis Media With Effiusion']}, 'referencesModule': {'references': [{'pmid': '38088821', 'type': 'DERIVED', 'citation': 'Mulvaney CA, Galbraith K, Webster KE, Rana M, Connolly R, Tudor-Green B, Marom T, Daniel M, Venekamp RP, Schilder AG, MacKeith S. Topical and oral steroids for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Dec 13;12(12):CD015255. doi: 10.1002/14651858.CD015255.pub2.'}, {'pmid': '28894551', 'type': 'DERIVED', 'citation': 'Rahmati MB, Safdarian F, Shiroui B, Zare S, Sadeghi N. Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial. Electron Physician. 2017 Jul 25;9(7):4890-4894. doi: 10.19082/4890. eCollection 2017 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Children who were between 2 to 6 years old\n\n * Definite diagnosis of OME with symptoms and examination\n\nExclusion Criteria:\n\n* • Currently were using corticosteroids or prophylactic monteleukast\n\n * Chronic pulmonary or cardiac diseases or immune deficiency\n * Allergic rhinitis\n * Hypersensitivity to monteleukast or corticosteroids\n * Avoidance of parents to fill the written informed consent'}, 'identificationModule': {'nctId': 'NCT02541760', 'briefTitle': 'Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children', 'orgStudyIdInfo': {'id': '163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast', 'description': '4 ml monteleukast daily for one month', 'interventionNames': ['Drug: Monteleukast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mometasone', 'description': 'Inhaled mometasone 1 puff in each side of nose for one month', 'interventionNames': ['Drug: Mometasone']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Monteleukast', 'type': 'DRUG', 'description': '4 ml monteleukast daily for one month', 'armGroupLabels': ['Montelukast']}, {'name': 'Mometasone', 'type': 'DRUG', 'description': 'Inhaled mometasone 1 puff in each side of nose for one month', 'armGroupLabels': ['Mometasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '097145-3388', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Hormozgan University of Medical Sciences', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}], 'overallOfficials': [{'name': 'Hamidreza Mahboobi, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hormozgan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hamidreza Mahboobi', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}