Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study
Juan Carlos Cardet, Paula J Busse, Jennifer K Carroll, Thomas B Casale, Tamera Coyne-Beasley, Sherrie Dixon-Williams, Maureen Fagan, Victoria E Forth, Anne L Fuhlbrigge, Michelle L Hernandez, David Kaelber, Barbara Kaplan, Margarita Lorenzi, Suzanne Madison, Nancy E Maher, Karen Majewski, Brian Manning, Melissa D McKee, Sylvette Nazario, Wilson D Pace, Michael J Pencina, Cynthia S Rand, Jacqueline Rodriguez-Louis, Lilin She, Joel Shields, Jessica E Teng, Michael E Wechsler, Juan P Wisnivesky, Barbara P Yawn, Elliot Israel, Juan Carlos Cardet, Paula J Busse, Jennifer K Carroll, Thomas B Casale, Tamera Coyne-Beasley, Sherrie Dixon-Williams, Maureen Fagan, Victoria E Forth, Anne L Fuhlbrigge, Michelle L Hernandez, David Kaelber, Barbara Kaplan, Margarita Lorenzi, Suzanne Madison, Nancy E Maher, Karen Majewski, Brian Manning, Melissa D McKee, Sylvette Nazario, Wilson D Pace, Michael J Pencina, Cynthia S Rand, Jacqueline Rodriguez-Louis, Lilin She, Joel Shields, Jessica E Teng, Michael E Wechsler, Juan P Wisnivesky, Barbara P Yawn, Elliot Israel
Abstract
Background: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown.
Objective: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols.
Methods: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures.
Results: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue."
Conclusion: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures.
Clinical trials registration: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).
Conflict of interest statement
Conflicts of Interest (COI): PJB reports receiving consulting fees or honoraria from CSL Behring, Shire/Takada, Pharming, Pearl Therapeutics, Biocryst, Novartis, the Law offices of Levin, Riback, Adelman and Flangel, Astra Zeneca, GSK, ResTORbio, Vedderprice, Fresenius and Dyax. PJB is on the board of the Hereditary Angioedema Association and the American Academy of Allergy, Asthma, and Immunology. TBC reports that his university employer has received grants and consulting fees from Genentech, Inc., and Novartis. EI reports receiving consultancy fees from AstraZeneca, Philips Respironics, Regeneron Pharmaceuticals, Birk Rock Bio, Nuvelution Pharmaceuticals, Vitaeris, Sanofi, and Merck. MEW reports personal fees from AstraZeneca, Vectura, Regeneron, Meda, Mylan, Gilacure, Tunitas, Genentech, Theravance, Neurotronic, Sentien, Teva, Boehringer Ingelheim, BSCI, and Novartis and grants from Sanofi and GlaxoSmithKline. JPW reports being a member of the research board of EHE International, and receiving lecture fees from Novartis Pharmaceutical, consulting honorarium from UBC, and a research grant from GlaxoSmithKline. BPY reports having served on asthma and COPD advisory boards for Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Teva. The rest of the authors declare that they have no relevant conflicts of interest.
Copyright © 2020 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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Source: PubMed