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Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.


ABSTRACT:

Background

Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.

Methods

In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.

Results

Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.

Conclusions

Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

SUBMITTER: Israel E 

PROVIDER: S-EPMC10367430 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

Israel Elliot E   Cardet Juan-Carlos JC   Carroll Jennifer K JK   Fuhlbrigge Anne L AL   She Lilin L   Rockhold Frank W FW   Maher Nancy E NE   Fagan Maureen M   Forth Victoria E VE   Yawn Barbara P BP   Arias Hernandez Paulina P   Kruse Jean M JM   Manning Brian K BK   Rodriguez-Louis Jacqueline J   Shields Joel B JB   Ericson Brianna B   Colon-Moya Alex D AD   Madison Suzanne S   Coyne-Beasley Tamera T   Hammer Gretchen M GM   Kaplan Barbara M BM   Rand Cynthia S CS   Robles Janet J   Thompson Opal O   Wechsler Michael E ME   Wisnivesky Juan P JP   McKee M Diane MD   Jariwala Sunit P SP   Jerschow Elina E   Busse Paula J PJ   Kaelber David C DC   Nazario Sylvette S   Hernandez Michelle L ML   Apter Andrea J AJ   Chang Ku-Lang KL   Pinto-Plata Victor V   Stranges Paul M PM   Hurley Laura P LP   Trevor Jennifer J   Casale Thomas B TB   Chupp Geoffrey G   Riley Isaretta L IL   Shenoy Kartik K   Pasarica Magdalena M   Calderon-Candelario Rafael A RA   Tapp Hazel H   Baydur Ahmet A   Pace Wilson D WD  

The New England journal of medicine 20220226 16


<h4>Background</h4>Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.<h4>Methods</h4>In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus u  ...[more]

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