Clinical trial NCT02298205: Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
Official title: Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-21
Enrollment: 206
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: asthma control (change in score of asthma control test)
timeFrame: 12 months
Secondary outcomes:
measure: Monthly cumulative dose of beclomethasone used
timeFrame: 12 months
measure: Lung function (FEV1)
timeFrame: 12 months
measure: Patient/parent satisfaction
timeFrame: 12 months
measure: Quality of life measurement
timeFrame: 12 months
measure: Asthma exacerbation
timeFrame: 12 month
measure: Missed School days
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: