TY - JOUR
T1 - Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma
AU - Israel, Elliot
AU - Cardet, Juan Carlos
AU - Carroll, Jennifer K.
AU - Fuhlbrigge, Anne L.
AU - She, Lilin
AU - Rockhold, Frank W.
AU - Maher, Nancy E.
AU - Fagan, Maureen
AU - Forth, Victoria E.
AU - Yawn, Barbara P.
AU - Hernandez, Paulina Arias
AU - Kruse, Jean M.
AU - Manning, Brian K.
AU - Rodriguez-Louis, Jacqueline
AU - Shields, Joel B.
AU - Ericson, Brianna
AU - Colon-Moya, Alex D.
AU - Madison, Suzanne
AU - Coyne-Beasley, Tamera
AU - Hammer, Gretchen M.
AU - Kaplan, Barbara M.
AU - Rand, Cynthia S.
AU - Robles, Janet
AU - Thompson, Opal
AU - Wechsler, Michael E.
AU - Wisnivesky, Juan P.
AU - McKee, M. Diane
AU - Jariwala, Sunit P.
AU - Jerschow, Elina
AU - Busse, Paula J.
AU - Kaelber, David C.
AU - Nazario, Sylvette
AU - Hernandez, Michelle L.
AU - Apter, Andrea J.
AU - Chang, Ku Lang
AU - Pinto-Plata, Victor
AU - Stranges, Paul M.
AU - Hurley, Laura P.
AU - Trevor, Jennifer
AU - Casale, Thomas B.
AU - Chupp, Geoffrey
AU - Riley, Isaretta L.
AU - Shenoy, Kartik
AU - Pasarica, Magdalena
AU - Calderon-Candelario, Rafael A.
AU - Tapp, Hazel
AU - Baydur, Ahmet
AU - Pace, Wilson D.
N1 - Publisher Copyright:
© 2022 Massachusetts Medical Society.
PY - 2022/4/21
Y1 - 2022/4/21
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJMoa2118813
DO - 10.1056/NEJMoa2118813
M3 - Article
C2 - 35213105
AN - SCOPUS:85128798660
SN - 0028-4793
VL - 386
SP - 1505
EP - 1518
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 16
ER -