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 |
|
| 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 |
 |
15-month follow-up for primary outcomes |
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