A Phase 4 interventional study of Asthma controller medication (Beclomethasone) adjustment strategy and Provider-based adjustment in Asthma, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 206 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
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Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter
Other: Provider-based adjustment
The dose of asthma controller medication is adjusted based on the symptoms
Other: Asthma controller medication (Beclomethasone) adjustment strategy
The participant will adjust the dose of Beclomethasone based on symptoms
The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them
asthma control (change in score of asthma control test)
Change in score of asthma control test at 12 month from baseline
Time frame: 12 months
Monthly cumulative dose of beclomethasone used
Time frame: 12 months
Lung function (FEV1)
Change in lung function at 12 months compared to baseline
Time frame: 12 months
Patient/parent satisfaction
Score of satisfaction questionnaire at the end of the study
Time frame: 12 months
Quality of life measurement
Change in score in Child health survey (asthma) and PROMIS asthma questionnaire
Time frame: 12 months
Asthma exacerbation
Rate of asthma exacerbation
Time frame: 12 month
Missed School days
Number of missed school days
Time frame: 12 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine