Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- asthma control (change in score of asthma control test)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 6-17 years old with physician diagnosed asthma for at least 6 months
- •Self or parent reported AA Race, or mixed race with at least one grandparent with AA race
- •Receiving asthma care by the participating primary care pediatrician
- •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)
- •Asthma Evaluation Questionnaire Score (AEQ)17 0 or 1 on all 3 questions
- •Pre-BD FEV1 ≥80% of predicted
- •No history or current history of smoking
- •Ability to provide baseline information at phone screening and randomization visit
- •Ability and willingness to provide informed consent
排除标准
- •Pre-BD FEV1<80% of predicted within 3 months
- •Asthma requiring daily combination therapy with medium to high dose ICS with LABA
- •History of Intubation, noninvasive ventilation or ICU admission for asthma exacerbation
- •Chronic oral corticosteroid therapy
- •Chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial
- •No landline telephone or cell phone to communicate with study staff
- •Non-English speaker
- •Another participant of ASIST in the same household
研究组 & 干预措施
Provider-based adjustment
Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter
干预措施: Provider-based adjustment (Other)
Symptom-based adjustment
The dose of asthma controller medication is adjusted based on the symptoms
干预措施: Asthma controller medication (Beclomethasone) adjustment strategy (Other)
结局指标
主要结局
asthma control (change in score of asthma control test)
时间窗: 12 months
Change in score of asthma control test at 12 month from baseline
次要结局
- Monthly cumulative dose of beclomethasone used(12 months)
- Quality of life measurement(12 months)
- Missed School days(12 months)
- Lung function (FEV1)(12 months)
- Asthma exacerbation(12 month)
- Patient/parent satisfaction(12 months)