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  • Research & Results
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  • Comparing Asthma Treatments: A Study ...

Comparing Asthma Treatments: A Study Focusing on African-American, Hispanic, and Latino Adults -- The PREPARE Study for PeRson EmPowered Asthma Relief

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Project Summary  

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

More than 25 million people in the United States have asthma. People with asthma experience attacks when the small muscles surrounding the lung airways get inflamed and tighten. Asthma attacks make breathing difficult. Symptoms may include shortness of breath, tightness in the chest, coughing, or wheezing (making a whistling sound while breathing). People with uncontrolled asthma attacks may end up in the emergency room or in the hospital. Regular asthma attacks can make normal daily activities difficult. People who have regular asthma attacks may miss work or school because of their symptoms or hospital visits.

People with asthma often use a reliever inhaler to ease their symptoms and to prevent asthma attacks that are more severe. Some people may use a second inhaler every day that contains a medicine called an inhaled corticosteroid (ICS). Treatment guidelines recommend that most people with asthma use an ICS inhaler daily to prevent attacks. However, some people may not want to take a medicine unless they have symptoms.

Some research studies have shown that using an ICS inhaler and a reliever inhaler at the same time when symptoms occur (instead of using an ICS inhaler every day) works well to control asthma and prevent attacks. Researchers want to know how well this approach works in real-world situations, and with African-American, Hispanic, and Latino adult asthma patients in particular. African-American, Hispanic, and Latino populations experience worse outcomes for asthma compared to white populations.

Who can this research help?

Findings from this study can help African-American, Hispanic, and Latino adults with asthma and their doctors choose a treatment strategy.

What is the research team doing?

The research team is recruiting 1,200 African-American, Hispanic, and Latino adults, age 18 to 75, who have asthma, use an ICS inhaler, and have had an asthma attack within the past year. All doctors treating the patients are getting training on how to use Asthma-IQ, an online system to help doctors learn about asthma treatment guidelines and use the guidelines to improve care for patients. The research team is assigning patients by chance to one of two groups. One group receives usual care from their doctors. The second group receives the usual care and the new asthma treatment approach. With the new treatment approach, patients use an ICS inhaler and a reliever inhaler at the same time when symptoms occur. Patients fill out surveys each month for 15 months. The surveys will report the number of asthma attacks, days missed from work or school, symptoms, and how well patients’ asthma is controlled.

Two groups of African-American and Hispanic or Latino patients with asthma are meeting regularly with the study team. The groups are giving input about designing and carrying out the study, recruiting patients, analyzing the results of the study, and sharing the results. One patient from each of the two groups is on the study’s leadership committee. Other people who are advising the research team include members of asthma-related advocacy groups, leaders of professional societies, experts from organizations that provide health care, insurance professionals, government officials, and experts in study design.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population African-American, Latino, and Hispanic adults age 18 to 75 years who have had asthma for more than 1 year and are prescribed a daily ICS inhaler or ICS/LABA inhaler. Patients who are prescribed ICS alone must have had an asthma attack within the past year or an asthma control test score of 19 or below, which indicates poor control. 
Interventions/
Comparators
  • Provider-educated care through the Asthma IQ system plus use of ICS inhaler and reliever inhaler at the same time when asthma symptoms occur
  • Provider-educated care through the Asthma IQ system
Outcomes

Primary: number of asthma-related attacks, emergency room visits, or hospitalizations that require treatment per patient per year

Secondary: days missed from work or school, asthma symptoms, asthma control score

Timeframe 15-month follow-up for primary outcomes

Journal Articles

Related Articles

Contemporary Clinical Trials

Real-world experiences with generating real-world evidence: Case Studies from PCORI's pragmatic clinical Studies program

Annals of Allergy, Asthma & Immunology

Adherence to Adding Inhaled Corticosteroids to Rescue Therapy in a Pragmatic Trial with Adults with Asthma- a Pilot Study

More on this Project  

Videos

Improving Treatment Strategies for Disadvantaged Populations with Asthma
Study Principal Investigator Elliot Israel, MD, shares how this study is comparing usual care versus usual care and the use of controller medications together with reliever medications to reduce asthma exacerbations in African-American, Latino, and Hispanic populations where asthma rates, severity, and hospitalizations are higher than other populations.

Project Details

Principal Investigator
Elliot Israel, MD
Project Status
In progress; Enrollment complete
Project Title
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PESRAMHIP)
Board Approval Date
January 2016
Project End Date
March 2023
Organization
Brigham and Women's Hospital
Year Awarded
2016
State
Massachusetts
Project Type
Research Project
Health Conditions  
Respiratory Diseases
Asthma
Intervention Strategies
Drug Interventions
Other Health Services Interventions
Incentives for Behavior Change
Training and Education Interventions
Populations
Racial/Ethnic Minorities
Funding Announcement
Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes
Project Budget
$14,492,022
Study Registration Information
HSRP20162202
NCT02995733
Page Last Updated: 
May 15, 2020

Research & Results

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Meetings & Events

March 2
Cycle 1 2021 PCORnet Phase 3 Applicant Town Hall
March 8
Engagement Awards 2021 Special Cycle -- Applicant Office Hours (One)
March 15
Priorities on the Health Horizon: Informing PCORI's Strategic Plan (Webinar)

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Phone: (202) 827-7700 | Fax: (202) 355-9558
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