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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Asthma controller medication (Beclomethasone) adjustment strategy

Provider-based adjustment

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Provider-based adjustment

Symptom-based adjustment

Arm Description

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

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

Outcomes

Primary Outcome Measures

asthma control (change in score of asthma control test)

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

Secondary Outcome Measures

Monthly cumulative dose of beclomethasone used

Lung function (FEV1)

Change in lung function at 12 months compared to baseline

Patient/parent satisfaction

Score of satisfaction questionnaire at the end of the study

Quality of life measurement

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

Asthma exacerbation

Rate of asthma exacerbation

Missed School days

Number of missed school days

Full Information

NCT ID

NCT02298205

First Posted

November 19, 2014

Last Updated

October 1, 2018

Sponsor

Washington University School of Medicine

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02298205

Brief Title

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

Acronym

ASIST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

October 31, 2017 (Actual)

Study Completion Date

October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Provider-based adjustment

Arm Type

Other

Arm Description

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

Arm Title

Symptom-based adjustment

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Asthma controller medication (Beclomethasone) adjustment strategy

Intervention Description

The participant will adjust the dose of Beclomethasone based on symptoms

Intervention Type

Other

Intervention Name(s)

Provider-based adjustment

Intervention Description

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

Primary Outcome Measure Information:

Title

asthma control (change in score of asthma control test)

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Monthly cumulative dose of beclomethasone used

Time Frame

12 months

Title

Lung function (FEV1)

Description

Change in lung function at 12 months compared to baseline

Time Frame

12 months

Title

Patient/parent satisfaction

Description

Score of satisfaction questionnaire at the end of the study

Time Frame

12 months

Title

Quality of life measurement

Description

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

Time Frame

12 months

Title

Asthma exacerbation

Description

Rate of asthma exacerbation

Time Frame

12 month

Title

Missed School days

Description

Number of missed school days

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

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

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