TY - JOUR
T1 - Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma
T2 - A pilot study
AU - Cardet, Juan Carlos
AU - Busse, Paula J.
AU - Carroll, Jennifer K.
AU - Casale, Thomas B.
AU - Coyne-Beasley, Tamera
AU - Dixon-Williams, Sherrie
AU - Fagan, Maureen
AU - Forth, Victoria E.
AU - Fuhlbrigge, Anne L.
AU - Hernandez, Michelle L.
AU - Kaelber, David
AU - Kaplan, Barbara
AU - Lorenzi, Margarita
AU - Madison, Suzanne
AU - Maher, Nancy E.
AU - Majewski, Karen
AU - Manning, Brian
AU - McKee, Melissa D.
AU - Nazario, Sylvette
AU - Pace, Wilson D.
AU - Pencina, Michael J.
AU - Rand, Cynthia S.
AU - Rodriguez-Louis, Jacqueline
AU - She, Lilin
AU - Shields, Joel
AU - Teng, Jessica E.
AU - Wechsler, Michael E.
AU - Wisnivesky, Juan P.
AU - Yawn, Barbara P.
AU - Israel, Elliot
N1 - Funding Information:
Disclosures: 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.
Funding Information:
Funding Sources: This study was funded by Patient-Centered Outcomes Research Institute ( PCORI ) grant, PCS-1504-30283. In addition, funding support was provided by K23AI125785 to JCC, R01HL135235 to MH, and generous contributions by the Culverhouse family fund to JCC and TBC .
Funding Information:
Disclosures: 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.Funding Sources: This study was funded by Patient-Centered Outcomes Research Institute (PCORI) grant, PCS-1504-30283. In addition, funding support was provided by K23AI125785 to JCC, R01HL135235 to MH, and generous contributions by the Culverhouse family fund to JCC and TBC.
Publisher Copyright:
© 2020 American College of Allergy, Asthma & Immunology
PY - 2020/5
Y1 - 2020/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85078855281&partnerID=8YFLogxK
U2 - 10.1016/j.anai.2019.12.027
DO - 10.1016/j.anai.2019.12.027
M3 - Article
C2 - 31923550
AN - SCOPUS:85078855281
SN - 1081-1206
VL - 124
SP - 487-493.e1
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 5
ER -