-
Randomized Controlled Trial
Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.
- Elliot Israel, Juan-Carlos Cardet, Jennifer K Carroll, Anne L Fuhlbrigge, Lilin She, Frank W Rockhold, Nancy E Maher, Maureen Fagan, Victoria E Forth, Barbara P Yawn, Paulina Arias Hernandez, Jean M Kruse, Brian K Manning, Jacqueline Rodriguez-Louis, Joel B Shields, Brianna Ericson, Alex D Colon-Moya, Suzanne Madison, Tamera Coyne-Beasley, Gretchen M Hammer, Barbara M Kaplan, Cynthia S Rand, Janet Robles, Opal Thompson, Michael E Wechsler, Juan P Wisnivesky, M Diane McKee, Sunit P Jariwala, Elina Jerschow, Paula J Busse, David C Kaelber, Sylvette Nazario, Michelle L Hernandez, Andrea J Apter, Ku-Lang Chang, Victor Pinto-Plata, Paul M Stranges, Laura P Hurley, Jennifer Trevor, Thomas B Casale, Geoffrey Chupp, Isaretta L Riley, Kartik Shenoy, Magdalena Pasarica, Rafael A Calderon-Candelario, Hazel Tapp, Ahmet Baydur, and Wilson D Pace.
- From the Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Brigham and Women's Hospital, Harvard Medical School (E.I., N.E.M., V.E.F., P.A.H., J.M.K., J.R.L., B.E.), and patient partner (O.T.), Boston, and the Lahey Hospital and Medical Center, Burlington (V.P.P.) - all in Massachusetts; the Division of Allergy and Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa (J.-C.C., T.B.C.), the Department of Nursing, University of Miami Health System (M.F.), and Miller School of Medicine, University of Miami (R.A.C.C.), Miami, the Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville (K.L.C.), and the University of Central Florida College of Medicine, Orlando (M.P.) - all in Florida; the Department of Family Medicine (J.K.C., W.D.P.) and the Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine (A.L.F.), University of Colorado, Aurora, the Public Leadership Group (G.M.H.), the Department of Medicine, National Jewish Health (M.E.W.), and the Denver Health and Hospital Authority (L.P.H.), Denver - all in Colorado; the American Academy of Family Physicians National Research Network, Leawood, KS (J.K.C., B.K.M., J.B.S.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (L.S., F.W.R.); the Department of Family and Community Health, University of Minnesota, Minneapolis (B.P.Y.), and patient partner, St. Paul (S.M.) - both in Minnesota; patient partner, South Jordan, UT (A.D.C.M.); the Division of Adolescent Medicine (T.C.B.) and the Lung Health Center, Department of Medicine, University of Alabama, Birmingham (J.T.); the American Lung Association, Washington, DC (B.M.K.); the Department of Medicine, Johns Hopkins School of Medicine, Baltimore (C.S.R.); patient partner (J.R.), the Divisions of General Internal Medicine and Pulmonary and Critical Care Medicine (J.P.W.) and Clinical Immunology and Allergy (P.J.B.), Icahn School of Medicine at Mount Sinai, and Montefiore Medical Center, (E.J.), Albert Einstein College of Medicine (M.D.M., S.P.J.) - all in New York; the Center for Clinical Informatics Research and Education, the MetroHealth System, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland (D.C.K.); the Department of Internal Medicine, Section of Allergy and Immunology, University of Puerto Rico, San Juan (S.N.); the Division of Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill (M.L.H.), the Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham (I.L.R.), and the Department of Family Medicine, Atrium Health, Charlotte (H.T.) - all in North Carolina; the Division of Pulmonary, Allergy, and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania (A.J.A.), and the Temple Lung Center, Lewis Katz School of Medicine at Temple University (K.S.) - both in Philadelphia; the University of Illinois at Chicago College of Pharmacy, Chicago (P.M.S.); the Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT (G.C.); and the Division of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles (A.B.).
- N. Engl. J. Med. 2022 Apr 21; 386 (16): 150515181505-1518.
BackgroundBlack 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.MethodsIn 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.ResultsOf 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.ConclusionsAmong 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.).Copyright © 2022 Massachusetts Medical Society.
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