Q&A: Improving Outcomes for Patients with Asthma Through Research
Elliot Israel
Approximately one in 14 people in the U.S. are affected by asthma, a chronic respiratory condition characterized by inflammation and narrowing of the airways which leads to difficulty in breathing. Current treatment guidelines recommend combining “rescue” medications, which manage acute symptoms during an asthma attack, and “maintenance” medications, which patients take for long-term treatment and prevention. These recommendations are based on results from studies of a strategy known as MART (previously known as SMART), in which patients took a rescue and maintenance medication in a combined dose delivered with a single inhaler. Other studies have used a strategy known as PARTICS, in which patients are instructed to take their maintenance medication along with their rescue medication when experiencing acute symptoms.
In April 2024, the Patient-Centered Outcomes Research Institute (PCORI) awarded Elliot Israel, MD, the BWH Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research and Professor of Medicine in the Pulmonary and Critical Care Division and the Allergy and Immunology Division and director of pulmonary function at Brigham and Women’s Hospital, a $22 million grant for his research study, Improving the Quality of Care for Asthma Patients at Risk of Exacerbations (iCARE). The study aims to compare the PARTICS and MART treatment strategies in adults with asthma at risk of exacerbations and to determine their effectiveness in managing patients’ symptoms.
Q: What do the current treatment guidelines for asthma look like today and what are they based on?
EI: Inhaled Corticosteroids (ICS), or maintenance medications, are the backbone of asthma treatment. Asthma patients are instructed to use their ICS daily for maintenance to decrease inflammation in the lungs. Beta agonists, or rescue medications, are used for quick relief of asthma symptoms like wheezing, coughing and shortness of breath, by opening the airways. Use of Maintenance And Reliever Therapy (MART) together has been recommended by U.S. and international guidelines for patients with moderate-severe asthma. Most of the studies examining the effectiveness of different treatments for asthma have been done using a combination of an inhaled corticosteroid and a long-acting reliever in one inhaler, and others have been done by instructing patients to take their maintenance inhaler every time they use their rescue. In these studies, these strategies all reduced asthma exacerbations. The U.S. Guidelines for asthma treatment recommend the single controller (maintenance) combined with the long-acting reliever (rescue) in moderate to severe asthma and using the controller every time a reliever is used in milder asthma.
While this is the recommended course of treatment, in the US the Food and Drug Administration specifically warns against using the two-in-one maintenance and rescue inhaler as a rescue therapy. This results in many insurers not covering the additional cannister needed to use for rescue. Additionally, in many other countries, those combined inhalers are very expensive and not available in many cases.
Q: What are the main differences between the MART and PARTICS asthma treatment methods?
EI: The MART strategy primarily involves prescribing the combination inhaler for maintenance and as needed for rescue. Previous studies utilizing MART therapy demonstrated a reduction in exacerbations, or asthma attacks, among moderate to severe asthma cases. However, these studies did not show significant improvements in patients’ symptoms. Notably, these studies excluded patients who administered their rescue medication with a nebulizer, a way of administering rescue medication that is used by 30-60% of patients with more severe asthma. Additionally, MART was primarily tested in white populations, not in Black and Latinx patients, who are disproportionately affected by moderate-severe asthma.
In contrast, the PARTICS strategy instructs patients to take a puff of their mainteance medication with each puff they take of their rescue medication and 5 puffs of their maintenance medication with each use of their nebulizer, if applicable. In our previous study, PREPARE, which examined the efficacy of the PARTICS strategy in Black and Latinx patients, PARTICS decreased asthma attacks, especially in participants with a history of exacerbations, increased asthma control and quality of life and decreased days lost from work, school and usual activities. PARTICS included patients who used a nebulizer for rescue, and they also improved with PARTICS.
Q: How will the iCARE study be designed to recruit individuals from minority and underprivileged communities and find solutions for them?
EI: Asthma is a significant burden for those in minority and underprivileged communities. While the iCARE study will recruit patients from a variety of backgrounds so the findings are applicable to all populations, it will be so large that we’ll be able to look at specific populations as well. To recruit Black and Latinx patients, we will have a few federally qualified health centers (FQHC) as study sites. FQHC qualify for federal aid because they treat predominantly underprivileged groups.
We will also have patient partners that are part of every aspect of the study to help us overcome barriers for individuals to participate in the study. In the PREPARE study, the patient partners helped us develop shorter questionnaires and encouraged us to simplify access to filling out the monthly surveys by sending a one-click link by text and email to accommodate participants’ busy schedules. In addition, they helped make sure that financial incentives were appropriate for the study participants’ time and delivered to them within 24 hours.
Q: What do you hope to achieve by the conclusion of the study?
EI: Our goal is to determine if PARTICS and MART are equally effective in decreasing exacerbations in at risk adults and increase asthma control and quality of life, focusing on both patients who use a nebulizer to deliver a rescue medication and those who do not.
Our primary outcome of interest is the reduction in the frequency of severe asthma attacks, as our patients have emphasized the significance of this aspect in maintaining their daily routines, including attending school or work and being able to do their usual activities including caring for their children and being able to work to support their family. However, we will also be powered to examine effects on asthma control and asthma quality of life which our patients have told us are important to them in deciding about asthma treatments.
Q: How do you anticipate the results impacting the way physicians care for patients with asthma?
EI: I think our study’s findings will underscore the importance of shared decision-making between physicians and patients, and the implementation of patient-centered care. Our goal is to give clinicians the information that patients want most so that patients will be able to make informed decisions about their care. We’ve observed that when patients are actively involved in creating their treatment plans, they feel more empowered and in control of their condition, leading to improved outcomes as they are more likely to adhere to the agreed-upon plan.
Q: What does receiving this funding mean for your team?
EI: I think that people at all levels of the study are dedicated to improving the lives of patients with asthma, which is why we went into this line of work. Our previous study helped provide data and publications for other investigators interested in how socioeconomic factors, the lived environment, COVID-19, and patient behavior influenced asthma outcomes. They have already published 11 papers in addition to the primary paper. Many of these papers have helped advance the careers of junior investigators in the asthma field. These analyses have further advanced our understanding of how to advance asthma care. It’s just a wonderful opportunity to be able to provide an evidence base for what you can and can’t do in terms of asthma treatment. The ability to conduct this research is empowering not just for the patients, but also for us.