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

Asthma Clinical Trial

— ASIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298205
• Other study ID #: HRPO201410095
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: October 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Asthma controller medication (Beclomethasone) adjustment strategy
The participant will adjust the dose of Beclomethasone based on symptoms
• Provider-based adjustment
The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma control (change in score of asthma control test)	Change in score of asthma control test at 12 month from baseline	12 months
Secondary	Monthly cumulative dose of beclomethasone used		12 months
Secondary	Lung function (FEV1)	Change in lung function at 12 months compared to baseline	12 months
Secondary	Patient/parent satisfaction	Score of satisfaction questionnaire at the end of the study	12 months
Secondary	Quality of life measurement	Change in score in Child health survey (asthma) and PROMIS asthma questionnaire	12 months
Secondary	Asthma exacerbation	Rate of asthma exacerbation	12 month
Secondary	Missed School days	Number of missed school days	12 months