Status:
COMPLETED
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Asthma
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients 6-17 years old with physician diagnosed asthma for at least 6 months
- Self or parent reported AA Race, or mixed race with at least one grandparent with AA race
- Receiving asthma care by the participating primary care pediatrician
- 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)
- Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions
- Pre-BD FEV1 ≥80% of predicted
- No history or current history of smoking
- Ability to provide baseline information at phone screening and randomization visit
- Ability and willingness to provide informed consent
Exclusion
- Pre-BD FEV1\<80% of predicted within 3 months
- Asthma requiring daily combination therapy with medium to high dose ICS with LABA
- History of Intubation, noninvasive ventilation or ICU admission for asthma exacerbation
- Chronic oral corticosteroid therapy
- Chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial
- No landline telephone or cell phone to communicate with study staff
- Non-English speaker
- Another participant of ASIST in the same household
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT02298205
Start Date
February 1 2015
End Date
October 31 2017
Last Update
October 2 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110