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NCT02298205 · ClinicalTrials.gov registry record · Phase 4
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 206
- Enrollment target
NCT02298205 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 206 participants.
The verdict
NCT02298205, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 206 participants
- Enrollment target
Study 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 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.
Interventions
- OTHER Asthma controller medication (Beclomethasone) adjustment strategy
- OTHER Provider-based adjustment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2015-02 |
| Est. Completion | 2017-10-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02298205
The ClinicalTrials.gov registry entry for NCT02298205 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Asthma controller medication (Beclomethasone) adjustment strategy is the first listed.
NCT02298205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02298205 about?
NCT02298205 is a clinical study titled "Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children". 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 describ...
What is the current status of trial NCT02298205?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 206 participants. The study started on 2015-02. Estimated completion is 2017-10-31.
What interventions are being tested in trial NCT02298205?
The interventions under investigation include: Asthma controller medication (Beclomethasone) adjustment strategy (OTHER), Provider-based adjustment (OTHER).
Who is sponsoring clinical trial NCT02298205?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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