Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 1:39 PM
Study NCT ID:
NCT01818635
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2013-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the effect of montelukast on behavior problems in children with asthma', 'timeFrame': '8 months', 'description': 'Montelukast frequently used in the treatment of asthmatic children. However, we believe that montelukast lead to behavior problems. In this study, we aimed to investigate that intake of montelukast whether lead to behavior problems.'}], 'secondaryOutcomes': [{'measure': 'To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.', 'timeFrame': '8 months', 'description': 'In this study, it will be compared the effect on behavior changes between intake of inhaled steroid and montelukast.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma, Behavior Problem, Montelukast']}, 'descriptionModule': {'briefSummary': 'The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We planned to include who who treated for asthmatic children and healthy controls in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To have asthmatic children aged 18-60 months\n* To have that receive prophylactic treatment for asthma\n* Healthy children will be enrolled among those being brought for routine controls\n\nExclusion Criteria:\n\n* Children with other chronic disease\n* Children with chronic drug use (except for the treatment of asthma)'}, 'identificationModule': {'nctId': 'NCT01818635', 'briefTitle': 'To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Fatih University'}, 'officialTitle': 'Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma', 'orgStudyIdInfo': {'id': 'FK-0663'}}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Fatih University Medical School', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06510', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Fatih University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kecioren Teaching and Research Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fatih University Medical School', 'investigatorFullName': 'Ahmet Z. Akelma', 'investigatorAffiliation': 'Fatih University'}}}}