Black and Latinx patients who used an inhaled glucocorticoid as needed along with usual care had improved asthma outcomes, according to results from the PREPARE trial.

In the study of patients with moderate-to-severe asthma, and compared to a control group that continued usual care only, the intervention group experienced a 15% decrease in risk of severe asthma exacerbation (hazard ratio 0.85, 95% CI 0.72-0.999, P=0.048), reported Elliot Israel, MD, of Brigham and Women’s Hospital in Boston, and colleagues at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, and simultaneously in the New England Journal of Medicine.

Patients in the intervention group received one-time instructions to take one puff of their inhaled glucocorticoid — which they were provided as part of the intervention — for each puff of their quick-reliever inhaler, and five puffs for each quick-reliever nebulization. Afterwards, they completed monthly surveys for 15 months, for which cash compensation was given.

While the annualized rate of severe asthma exacerbations was 0.82 (95% CI 0.73 to 0.92) in the usual care group, it was 0.69 (95% CI 0.61 to 0.78) in the intervention group, the authors stated.

Black and Latinx adults disproportionately bear the burden of asthma in the U.S., and “That’s been very hard to crack,” Israel told MedPage Today. In PREPARE, approximately half the study population were Black and about half were Latinx, with 5.3% reporting being both (latter patients were classified as Latinx for the purpose of stratification, the authors noted).

Past interventions for these populations have been “labor-intensive,” including weekly check-ins with nurses, and were not scalable, he said. In comparison with those past strategies, the one in the PREPARE trial is “shovel-ready…[it would be] easy to adopt both for providers and for patients,” Israel said.

Current guidelines recommend single maintenance and reliever therapy (SMART) for adults with moderate-to-severe asthma, consisting of a single inhaler with combined and inhaled corticosteroid and formoterol. However, uptake of SMART therapy has been slow, the researchers noted, due to a 2011 FDA safety warning about the combination therapy, which was later removed in 2018, and limited insurance coverage.

“The first SMART trial was published in 2005,” co-author Juan Carlos Cardet, MD, MPH, of the University of South Florida in Tampa, said at an AAAAI press conference. “But if I want to introduce [SMART] to my patients, I’m unable to do so.” Cardet also noted that SMART has not been tested specifically in Black and Latinx adults or in patients who rely on nebulizers.

“SMART studies have been very curated,” Israel said, noting that they excluded patients with certain conditions, and required an asthma exacerbation in the past year as well as a bronchodilator test. As a result, “we don’t know how effective [SMART] is in the real world,” he said.

In contrast, PREPARE had broad inclusion criteria: It did not require an asthma exacerbation or bronchodilator test, and one-fifth of the study population were current or former smokers. Unlike SMART trials, this intervention allowed patients to continue to use their nebulizers, and 66.9% of the study population continued to do so, with 45.2% reporting at least one nebulizer use per week, Israel said.

Overall, the intervention group’s asthma control test (ACT) scores improved by 3.4 points versus a 2.5 point increase in the usual care group (minimal clinically important difference of 3 points), the authors reported. The intervention group also missed fewer days of work, school, and other activities than the usual care group (13.4 vs 16.8 annualized days missed, rate ratio 0.80, 95% CI 0.67-0.95), they said.

In post-hoc analysis, Israel and colleagues found that participants in the intervention group reported using 1.1 extra inhalers with inhaled glucocorticoid per year compared with the usual care group, but one fewer refill of the quick-reliever metered-dose inhaler, and fewer months using the quick-reliever nebulizer (3.6 vs 5.4 months).

They also found that 12% of participants experienced adverse events (AEs), such as asthma, infection or infestation, and cardiac events, and AEs were split evenly across the two groups. There were three deaths in the intervention group and four in the usual care group, none of which were asthma-related, the authors stated.

The PREPARE trial ran from November 2017 to March 2021 with a total of 1,201 adults with moderate-to-severe asthma and a previous prescription for inhaled glucocorticoids. Of those, 600 were randomized to the intervention arm and 601 to the usual care group. The mean age of the participants was 47.7, 83.7% were women, and 68.8% were obese.

“All the participants received a trial-specific pouch designed to hold two metered-dose inhalers,” they stated. Those in the intervention group got an open-label inhaler (QVAR RediHaler) that administered a metered dose of 80 μg of beclomethasone dipropionate plus usual care. Usual care was determined by the treating clinician. Around 96% of both groups returned the surveys.

The researchers collaborated with patient partners to design the intervention. One patient partner and study co-author, Opal Thompson, told MedPage Today that her role was to represent the everyday people with asthma, and provide feedback on the different aspects of the study design and instruction materials. An asthma patient of Israel’s, Thompson said her involvement helped to create a community with other asthma patients.

“A lot of times we forget how disempowering being sick is,” Israel said at the press conference. “Here, you’re in control.”

The researchers noted that women were overrepresented in the study, although they pointed out that women have a greater asthma prevalence versus men. They also acknowledged that the study population consisted of many ethnic groups that may have different asthma morbidities and responsiveness to the intervention.

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