A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial

Elliot Israel, Juan Carlos Cardet, Jennifer K. Carroll, Anne L. Fuhlbrigge, Wilson D. Pace, Nancy E. Maher, Lilin She, Frank W. Rockhold, Maureen Fagan, Victoria E. Forth, Paulina Arias Hernandez, Brian K. Manning, Jacqueline Rodriguez-Louis, Joel B. Shields, Tamera Coyne-Beasley, Barbara M. Kaplan, Cynthia S. Rand, Wilfredo Morales-Cosme, Michael E. Wechsler, Juan P. WisniveskyMary White, Barbara P. Yawn, M. Diane McKee, 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

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Original languageEnglish (US)
Article number106246
JournalContemporary Clinical Trials
Volume101
DOIs
StatePublished - Feb 2021

Keywords

  • African American
  • Asthma
  • Exacerbations
  • Hispanic
  • Patient-centered
  • Pragmatic trial

ASJC Scopus subject areas

  • Pharmacology (medical)

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