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

NCT02298205 | Completed Phase 4 DMC

• 1 other identifier: HRPO201410095
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• asthma control (change in score of asthma control test)

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

  12 months

Secondary Outcomes (6)

• Monthly cumulative dose of beclomethasone used

  12 months

• Lung function (FEV1)

  12 months

• Patient/parent satisfaction

  12 months

• Quality of life measurement

  12 months

• Asthma exacerbation

  12 month

Study Arms (2)

Provider-based adjustment

OTHER

Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter

Other: Provider-based adjustment

Symptom-based adjustment

ACTIVE COMPARATOR

The dose of asthma controller medication is adjusted based on the symptoms

Other: Asthma controller medication (Beclomethasone) adjustment strategy

Interventions

Asthma controller medication (Beclomethasone) adjustment strategy OTHER

The participant will adjust the dose of Beclomethasone based on symptoms

Symptom-based adjustment

Provider-based adjustment OTHER

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

Provider-based adjustment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: February 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

US (1)