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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provider-based adjustment | Other | Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter |
|
| Symptom-based adjustment | Active Comparator | The dose of asthma controller medication is adjusted based on the symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asthma controller medication (Beclomethasone) adjustment strategy | Other | The participant will adjust the dose of Beclomethasone based on symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| asthma control (change in score of asthma control test) | Change in score of asthma control test at 12 month from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monthly cumulative dose of beclomethasone used | 12 months | |
| Lung function (FEV1) | Change in lung function at 12 months compared to baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Provider-based adjustment | Other | The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them |
|
| Patient/parent satisfaction | Score of satisfaction questionnaire at the end of the study | 12 months |
| Quality of life measurement | Change in score in Child health survey (asthma) and PROMIS asthma questionnaire | 12 months |
| Asthma exacerbation | Rate of asthma exacerbation | 12 month |
| Missed School days | Number of missed school days | 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |