A new approach to managing moderate-to-severe asthma has led to updated guidelines for patients, but studies to date have not focused on populations that face a disproportionate burden of complications from asthma: African American/Black (AA/B) and Hispanic/Latinx (H/L) populations. AA/B and H/L individuals experience higher rates of asthma-related emergency department visits, higher rates of hospitalizations and approximately double the asthma mortality rate compared to white individuals.
In the real-world PREPARE (PeRson EmPowered Asthma RElief) trial, AA/B and H/L patients with asthma received one-time instruction to use inhaled corticosteroids (ICS) when they used an asthma reliever or nebulizer in addition to whatever medications they were taking for asthma. In data presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and published in The New England Journal of Medicine, investigators from Brigham and Women’s Hospital and their collaborators at 19 sites in the U.S. and Puerto Rico, including Temple University Hospital, demonstrated that this new intervention decreased the risk of severe asthma exacerbations by 15 percent (0.13 exacerbations per patient per year) and reduced asthma symptoms and days of impairment in AA/B and H/L patients with moderate-to-severe asthma. The 0.13 exacerbation reduction was equivalent to the reductions seen in previous studies that led the National Heart Lung and Blood Institute to update recommendations for patients with moderate-to-severe asthma.
Kartik V. Shenoy, MD, Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University, and Associate Program Director of the Pulmonary and Critical Care Fellowship at the Katz School of Medicine, helped execute this study. “Asthma exacerbations greatly impact patients’ quality of life, with Black and Latinx patients bearing a disproportionate burden. We are pleased to be a part of research that addresses these disparities,” Dr. Shenoy said.
“Despite a focus on interventions, a disproportionate burden of asthma on underserved populations in the U.S. persists,” said the study leader Elliot Israel, MD, the Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research and director of Clinical Research in the Brigham’s Pulmonary and Critical Care Division. “Results of the PREPARE trial show us that we can help reduce the impact of asthma through the simple, patient-centered intervention of having patients use ICS whenever they use their rescue inhaler or nebulizer to treat symptoms. This intervention is effective — easy to implement, easy to use, and comes at a low cost.”
Previous studies of a strategy known as SMART have indicated that, in patients with moderate-to-severe asthma, using combination ICS with formoterol (a long-acting reliever) (ICS/formoterol) twice a day and when symptoms arise could help patients control asthma symptoms better than if they were instructed to only use ICS/formoterol twice daily. Nearly all these studies were not real-world studies and did not take into account that most patients do not use their medications twice a day. They also did not include many Black or Latinx patients.
Israel and colleagues designed the PREPARE trial to determine if a patient- and provider-friendly approach that did not involve changing underlying medications — taking an ICS whenever patients used their reliever canisters or nebulizers — could help improve outcomes in the real world for populations who have been underrepresented in research but bear a disproportionate burden of disease.
One of the unique aspects of the PREPARE trial was the degree of engagement and involvement of patients in the trial’s design and implementation. Investigators collaborated with AA/B and H/L adults with asthma as well as asthma caregivers — called Patient Partners — who are among the NEJM paper’s co-authors.
PREPARE was a randomized, open-label, pragmatic study conducted from November 2017 to April 2021. The study included 1,201 adults with moderate-to-severe asthma who were randomized to receive one-time instruction for using ICS as needed (an intervention known as Patient-Activated Reliever-Triggered ICS, or PARTICS) in addition to usual care (UC) or to continue their usual care (control). Participants were followed for 15 months. There was only one study visit, and at that visit, participants received instructions, completed questionnaires, and watched a video appropriate to their arm of randomization. All materials were also available in Spanish.
More than 70 percent of participants reported at least one asthma exacerbation in the previous year and 67 percent reported using a nebulizer for quick-reliever treatment.
For participants in the PARTICS+UC group, the annualized rate of severe asthma exacerbations was 0.69 per patient; the rate was 0.82 for the control group. Participants in the PARTICS+UC group also had improved scores for asthma control and symptoms compared to participants in the control group. Those in the PARTICS+UC group also missed fewer days of school/work/usual activities compared to the control group (13.4 versus 16.8 days).
The authors note that this was an open-label study and ICS was provided at no cost but the calculated total extra controller use was 1.1 canisters a year which was far less than the extra controller used in SMART studies. Women were over-represented in PREPARE, but women also account for two-thirds of adult patients with asthma.
“This intervention appears to be an easy-to-implement strategy that improves outcomes for AA/B and H/L patients,” said Israel. “The outcome was achieved after a single visit and appeared durable, potentially offering a cost-effective, patient-centered way to reduce severe asthma exacerbations.”
Disclosures: The study was funded by the Patient-Centered Outcomes Research Institute. The extra inhaled corticosteroid and pharmacy services were provided by Teva Pharmaceuticals. Exhaled nitric oxide meters were generously provided by Circassia Pharmaceuticals Inc.
Funding: This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283) to Elliot Israel at the Brigham and Women’s Hospital. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. Elliot Israel’s work was additionally supported by the Gloria M. and Anthony Simboli Distinguished Chair in Asthma Research Award. Juan Carlos Cardet’s work was additionally funded by grant #K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID) and grant #AI-835475 from the American Lung Association (ALA)/American Academy of Allergy, Asthma & Immunology (AAAAI). QVAR® and QVAR Redihaler® inhalers and support for the AssistRx pharmacy (Orlando, FL) were generously provided by Teva Branded Pharmaceuticals Products R&D, Inc. (Malvern, PA). NIOX VERO® devices for measuring exhaled nitric oxide were generously provided by Circassia Pharmaceuticals, Inc. (Morrisville, NC).