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

Publication ,  Journal Article
Israel, E; Cardet, J-C; Carroll, JK; Fuhlbrigge, AL; She, L; Rockhold, FW; Maher, NE; Fagan, M; Forth, VE; Yawn, BP; Arias Hernandez, P ...
Published in: N Engl J Med
April 21, 2022

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 21, 2022

Volume

386

Issue

16

Start / End Page

1505 / 1518

Location

United States

Related Subject Headings

  • Symptom Flare Up
  • Surveys and Questionnaires
  • Quality of Life
  • Humans
  • Hispanic or Latino
  • Glucocorticoids
  • General & Internal Medicine
  • Black or African American
  • Beclomethasone
  • Asthma
 

Citation

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Israel, E., Cardet, J.-C., Carroll, J. K., Fuhlbrigge, A. L., She, L., Rockhold, F. W., … Pace, W. D. (2022). Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med, 386(16), 1505–1518. https://doi.org/10.1056/NEJMoa2118813
Israel, Elliot, Juan-Carlos Cardet, Jennifer K. Carroll, Anne L. Fuhlbrigge, Lilin She, Frank W. Rockhold, Nancy E. Maher, et al. “Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.N Engl J Med 386, no. 16 (April 21, 2022): 1505–18. https://doi.org/10.1056/NEJMoa2118813.
Israel E, Cardet J-C, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, et al. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505–18.
Israel, Elliot, et al. “Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.N Engl J Med, vol. 386, no. 16, Apr. 2022, pp. 1505–18. Pubmed, doi:10.1056/NEJMoa2118813.
Israel E, Cardet J-C, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang K-L, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505–1518.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 21, 2022

Volume

386

Issue

16

Start / End Page

1505 / 1518

Location

United States

Related Subject Headings

  • Symptom Flare Up
  • Surveys and Questionnaires
  • Quality of Life
  • Humans
  • Hispanic or Latino
  • Glucocorticoids
  • General & Internal Medicine
  • Black or African American
  • Beclomethasone
  • Asthma