Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children — ASIST  

Asthma Clinical Trial

Official title: Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT02298205
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Completion date: October 31, 2017