Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT01326494
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2011-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2011-03-29', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of representation to Health Services for Exacerbation of URTI induced asthma', 'timeFrame': 'One year', 'description': 'To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Upper Respiratory Tract Infection', 'Asthma', 'URTI induced exacerbation of Asthma'], 'conditions': ['Upper Respiratory Tract Infection', 'Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.', 'detailedDescription': "In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.\n\nExperts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.\n\nThe criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 or more presentations to Emergency department in a 12 month period\n\nExclusion Criteria:\n\n* less then 2 presentations to Emergency department in a 12 month period'}, 'identificationModule': {'nctId': 'NCT01326494', 'briefTitle': 'Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia', 'orgStudyIdInfo': {'id': 'H10-00184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 Oral Cortico Steroid', 'description': 'A filled prescription will be given to be used upon early onset of symptoms.', 'interventionNames': ['Drug: Arm 1 Oral Cortico Steroids']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care for Asthma treatment', 'description': 'monitor the readmission of URTI induced asthma in children over a 12 month period'}], 'interventions': [{'name': 'Arm 1 Oral Cortico Steroids', 'type': 'DRUG', 'otherNames': ['Prednisone'], 'description': "Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.\n\nDexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )", 'armGroupLabels': ['Arm 1 Oral Cortico Steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Bruce Carleton, B.Pharm, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Bruce Carleton', 'investigatorAffiliation': 'University of British Columbia'}}}}