Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT00406094
Status:
UNKNOWN
Last Update Posted:
2009-01-16
First Post:
2006-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-11-04', 'releaseDate': '2014-10-30'}], 'estimatedResultsFirstSubmitDate': '2014-10-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-15', 'studyFirstSubmitDate': '2006-11-30', 'studyFirstSubmitQcDate': '2006-11-30', 'lastUpdatePostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES', 'timeFrame': 'December 2008'}, {'measure': 'Determine whether montelukast is more effective than placebo at reducing nasal symptom scores', 'timeFrame': 'December 2008'}]}, 'conditionsModule': {'keywords': ['NARES', 'eosinophils', 'nasal symptoms'], 'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.', 'detailedDescription': 'Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 - 65 years\n* Diagnosed with NARES\n\nExclusion Criteria:\n\n* Smokers, exposed to passive smoke\n* Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)'}, 'identificationModule': {'nctId': 'NCT00406094', 'briefTitle': 'Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)', 'organization': {'class': 'INDIV', 'fullName': 'Bernstein, Jonathan A., M.D.'}, 'officialTitle': 'The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)', 'orgStudyIdInfo': {'id': 'NARES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'montelukast', 'interventionNames': ['Drug: montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'montelukast', 'type': 'DRUG', 'otherNames': ['Singulair'], 'description': '10mg', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan A Bernstein, MD', 'role': 'CONTACT', 'email': 'bernsteincrc@fuse.net', 'phone': '513-931-0775'}, {'name': 'Jonathan A Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bernstein Allergy Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Jonathan A Bernstein, MD', 'role': 'CONTACT', 'email': 'bernsteincrc@fuse.net', 'phone': '513-931-0775'}], 'overallOfficials': [{'name': 'Jonathan A Bernstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bernstein Allergy Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bernstein, Jonathan A., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jonathan A. Bernstein, MD', 'oldOrganization': 'Bernstein Clinical Research Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-10-30', 'type': 'RELEASE'}, {'date': '2014-11-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jonathan A. Bernstein, MD, Jonathan A. Bernstein, MD, Bernstein, Jonathan A., M.D.'}}}}