AsthmaPhase 4ASISTNCT02298205
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
A Phase 4 study testing Provider-based adjustment in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Provider-based adjustment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 31 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Asthma controller medication (Beclomethasone) adjustment strategy, Provider-based adjustment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma controller medication (Beclomethasone) adjustment strategyOther
The participant will adjust the dose of Beclomethasone based on symptoms
Provider-based adjustmentOther
The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them
| Study group | Role | What they receive |
|---|---|---|
| Provider-based adjustment | Other | Primary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter Receives: Other: Provider-based adjustment |
| Symptom-based adjustment | Active comparator | The dose of asthma controller medication is adjusted based on the symptoms Receives: Other: Asthma controller medication (Beclomethasone) adjustment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control (change in score of asthma control test)
Change in score of asthma control test at 12 month from baseline
Measured: 12 months
Secondary outcomes (6)
Monthly cumulative dose of beclomethasone used
Measured: 12 months
Lung function (FEV1)
Change in lung function at 12 months compared to baseline
Measured: 12 months
Patient/parent satisfaction
Score of satisfaction questionnaire at the end of the study
Measured: 12 months
Quality of life measurement
Change in score in Child health survey (asthma) and PROMIS asthma questionnaire
Measured: 12 months
Asthma exacerbation
Rate of asthma exacerbation
Measured: 12 month
Missed School days
Number of missed school days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298205
- Sponsor's protocol ID
- HRPO201410095
- Acronym
- ASIST
- Status last verified
- Oct 2018
- First submitted
- 19 Nov 2014
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
- ClinicalTrials.gov ID
- NCT02298205
- Acronym / sponsor ID
- ASIST / HRPO201410095
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Feb 2015 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider-based adjustment | Other | Other: Provider-based adjustmentPrimary care provider will adjust the dose of asthma controller medication based on asthma control at each encounter |
| Symptom-based adjustment | Active comparator | Other: Asthma controller medication (Beclomethasone) adjustment strategyThe dose of asthma controller medication is adjusted based on the symptoms |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma controller medication (Beclomethasone) adjustment strategyThe participant will adjust the dose of Beclomethasone based on symptoms | Other | Symptom-based adjustment |
| Provider-based adjustmentThe provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them | Other | Provider-based adjustment |
Primary outcome
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
6 secondary outcomes
Monthly cumulative dose of beclomethasone used
Time frame: 12 months
Lung function (FEV1)
Time frame: 12 months
Patient/parent satisfaction
Time frame: 12 months
Quality of life measurement
Time frame: 12 months
Asthma exacerbation
Time frame: 12 month
Missed School days
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provider-based adjustment in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asthma control (change in score of asthma control test) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.