Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-03-05 @ 4:14 AM
Study NCT ID:
NCT02195258
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2013-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva from patient were collected using Oragen®.DNA OG-500 kit, (DNA Genotek, Kanata, Canada) or swabs (Catch-All™ sample collection swabs from Epicentre Biotechnologies, Madison, WI), and stored at room temperature or -20°C, respectively.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2013-07-04', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)', 'timeFrame': 'Day 0', 'description': 'comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x \\[post-FEV1 - pre-FEV1\\]/pre-FEV1) between the different polymorphism'}], 'secondaryOutcomes': [{'measure': 'polymorphism on the response delay', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department', 'detailedDescription': 'Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children\n* 6-16 years old\n* asthmatic patients\n* consulting for an exacerbation in a pediatric emergency department\n* parental informed consent\n\nExclusion Criteria:\n\n* comorbidity\n* peak flow no available\n* pneumonia'}, 'identificationModule': {'nctId': 'NCT02195258', 'acronym': 'Pegase', 'briefTitle': 'Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Necker-Enfants Malades'}, 'officialTitle': 'Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department', 'orgStudyIdInfo': {'id': 'URC Paris centre'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'salbutamol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker Enfants Malades Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Hélène Chappuy, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Ph D', 'investigatorFullName': 'Helene Chappuy', 'investigatorAffiliation': 'Hôpital Necker-Enfants Malades'}}}}