Skip to main content
OpenTrials
Completed

NCT Number: NCT02298205

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Asthma controller medication (Beclomethasone) adjustment strategy

Other

The participant will adjust the dose of Beclomethasone based on symptoms

Provider-based adjustment

Other

The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them

Primary outcomes

  1. asthma control (change in score of asthma control test)

    Time frame: 12 months

    Change in score of asthma control test at 12 month from baseline

Secondary outcomes

  1. Monthly cumulative dose of beclomethasone used

    Time frame: 12 months

  2. Lung function (FEV1)

    Time frame: 12 months

    Change in lung function at 12 months compared to baseline

  3. Patient/parent satisfaction

    Time frame: 12 months

    Score of satisfaction questionnaire at the end of the study

  4. Quality of life measurement

    Time frame: 12 months

    Change in score in Child health survey (asthma) and PROMIS asthma questionnaire

  5. Asthma exacerbation

    Time frame: 12 month

    Rate of asthma exacerbation

  6. Missed School days

    Time frame: 12 months

    Number of missed school days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: ASIST

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2014
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.