Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-07 @ 8:31 PM
Study NCT ID:
NCT00599534
Status:
WITHDRAWN
Last Update Posted:
2017-04-10
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator has transferred to another Institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.', 'timeFrame': 'Duration of Study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '27439031', 'type': 'DERIVED', 'citation': 'Kheirandish-Gozal L, Bandla HP, Gozal D. Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial. Ann Am Thorac Soc. 2016 Oct;13(10):1736-1741. doi: 10.1513/AnnalsATS.201606-432OC.'}]}, 'descriptionModule': {'briefSummary': 'Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\\&A for OSAS.\n\n\\- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\\&A.', 'detailedDescription': 'Primary Specific Aim. To conduct a randomized double blind 16-week trial comparing the effect on polysomnographic measures of the administration of once a day oral montelukast therapy vs. placebo in children with OSAS.\n\nSecondary Specific Aim. For all children with the original AHI at diagnosis of \\>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic snoring children \\> 2 years of age and \\< 10 years of age, who snore and have an apnea hypopnea index (AHI) \\>2/hrTST (hour total sleep time), and in whom T\\&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.\n\nExclusion Criteria:\n\n* Hypersensitivity to montelukast\n* Immunodeficiency or immunosuppressant therapy\n* Craniofacial, neuromuscular, syndromic or defined genetic abnormalities\n* Acute upper respiratory tract infection\n* Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study\n* Children who already had adenotonsillectomy.\n\nIn addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.'}, 'identificationModule': {'nctId': 'NCT00599534', 'briefTitle': 'Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.', 'orgStudyIdInfo': {'id': 'IRB# 07.0135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '4 mg tablet for 16 weeks', 'interventionNames': ['Drug: Montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '5 mg for 16 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'description': '4 mg oral tablets', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '5mg tablets', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Pediatric Sleep Medicine Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Pediatrics Sleep Medicine Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Leila Kheirandish, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}, {'name': 'Lelia Kheirandish', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}