Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 10/4/2018 |
| Start Date: | February 2015 |
| End Date: | October 31, 2017 |
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.
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.
Inclusion Criteria:
1. Patients 6-17 years old with physician diagnosed asthma for at least 6 months
2. Self or parent reported AA Race, or mixed race with at least one grandparent with AA
race
3. Receiving asthma care by the participating primary care pediatrician
4. 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)
5. Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions
6. Pre-BD FEV1 ≥80% of predicted
7. No history or current history of smoking
8. Ability to provide baseline information at phone screening and randomization visit
9. Ability and willingness to provide informed consent
Exclusion Criteria:
1. Pre-BD FEV1<80% of predicted within 3 months
2. Asthma requiring daily combination therapy with medium to high dose ICS with LABA
3. History of Intubation, noninvasive ventilation or ICU admission for asthma
exacerbation
4. Chronic oral corticosteroid therapy
5. Chronic disease that in the opinion of the investigator/primary care provider would
prevent participation in the trial
6. No landline telephone or cell phone to communicate with study staff
7. Non-English speaker
8. Another participant of ASIST in the same household
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-8045
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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