Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02298205
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001507', 'term': 'Beclomethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asthma control (change in score of asthma control test)', 'timeFrame': '12 months', 'description': 'Change in score of asthma control test at 12 month from baseline'}], 'secondaryOutcomes': [{'measure': 'Monthly cumulative dose of beclomethasone used', 'timeFrame': '12 months'}, {'measure': 'Lung function (FEV1)', 'timeFrame': '12 months', 'description': 'Change in lung function at 12 months compared to baseline'}, {'measure': 'Patient/parent satisfaction', 'timeFrame': '12 months', 'description': 'Score of satisfaction questionnaire at the end of the study'}, {'measure': 'Quality of life measurement', 'timeFrame': '12 months', 'description': 'Change in score in Child health survey (asthma) and PROMIS asthma questionnaire'}, {'measure': 'Asthma exacerbation', 'timeFrame': '12 month', 'description': 'Rate of asthma exacerbation'}, {'measure': 'Missed School days', 'timeFrame': '12 months', 'description': 'Number of missed school days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'African American (AA) children carry a disproportionate burden of mortality and morbidity in asthma. A major contributor to racial disparity in asthma is lack of adherence to guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal of our study is to identify an acceptable, pragmatic and effective approach to asthma management in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more acceptable than provider-based adjustment (PBA), equally effective in improving pediatric asthma outcomes, and will reduce the cumulative dose of ICS needed for asthma control. Therefore, in the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African American children (ASIST) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which we will randomly assign 200 AA children to either receive SBA or PBA for 12 months. The primary outcome is asthma control as measured by the Asthma Control Test (ACT). We propose that asthma control in the SBA group will be equivalent to the PBA group after 12 months. Secondary outcomes include monthly cumulative ICS dose, exacerbation rate, quality of life, lung function, adherence and satisfaction with the treatment plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 6-17 years old with physician diagnosed asthma for at least 6 months\n2. Self or parent reported AA Race, or mixed race with at least one grandparent with AA race\n3. Receiving asthma care by the participating primary care pediatrician\n4. Prescribed low dose ICS monotherapy (up to Beclomethasone 160mcg for 6-11 y/o, 240 mcg per day for over 12 year old or equivalent), or leukotriene receptor antagonist (LTRA), or low dose ICS plus LABA (for over 12 year old) for at least the past 12 weeks, regardless of adherence (see ASIST low dose ICS inclusion table for conversion of dose)\n5. Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions\n6. Pre-BD FEV1 ≥80% of predicted\n7. No history or current history of smoking\n8. Ability to provide baseline information at phone screening and randomization visit\n9. Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Pre-BD FEV1\\<80% of predicted within 3 months\n2. Asthma requiring daily combination therapy with medium to high dose ICS with LABA\n3. History of Intubation, noninvasive ventilation or ICU admission for asthma exacerbation\n4. Chronic oral corticosteroid therapy\n5. Chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial\n6. No landline telephone or cell phone to communicate with study staff\n7. Non-English speaker\n8. Another participant of ASIST in the same household'}, 'identificationModule': {'nctId': 'NCT02298205', 'acronym': 'ASIST', 'briefTitle': 'Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children', 'orgStudyIdInfo': {'id': 'HRPO201410095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Provider-based adjustment', 'description': 'Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter', 'interventionNames': ['Other: Provider-based adjustment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symptom-based adjustment', 'description': 'The dose of asthma controller medication is adjusted based on the symptoms', 'interventionNames': ['Other: Asthma controller medication (Beclomethasone) adjustment strategy']}], 'interventions': [{'name': 'Asthma controller medication (Beclomethasone) adjustment strategy', 'type': 'OTHER', 'description': 'The participant will adjust the dose of Beclomethasone based on symptoms', 'armGroupLabels': ['Symptom-based adjustment']}, {'name': 'Provider-based adjustment', 'type': 'OTHER', 'description': "The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them", 'armGroupLabels': ['Provider-based adjustment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}