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Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials.

Authors :
VanDevanter, D.R.
Zemanick, E.T.
Konstan, M.W.
Ren, C.L.
Odem-Davis, K.
Emerman, I.
Young, J.
Mayer-Hamblett, N.
Source :
Journal of Cystic Fibrosis. Jul2023, Vol. 22 Issue 4, p652-655. 4p.
Publication Year :
2023

Abstract

• Willingness to enroll in clinical trials was assessed for those on CFTR modulators. • Willingness to enroll was associated with proposed trial length and comparator. • Shorter trials and active comparators were favored over alternatives. • Future studies in people on CFTR modulators will be feasible for some trial designs. To assess the feasibility of enrolling people with CF (pwCF) taking the CFTR modulator elexacaftor/tezacaftor/ivacaftor (ETI) in clinical trials of a new modulator. PwCF receiving ETI at CHEC-SC study (NCT03350828) enrollment were surveyed for interest in 2-week to 6-month placebo- (PC) and active-comparator (AC) modulator studies. Those taking inhaled antimicrobials (inhABX) were surveyed for interest in PC inhABX studies. Of 1791 respondents, 75% [95% CI 73, 77] would enroll in a 2-week PC modulator study versus 51% [49, 54] for a 6-month study; 82% [81, 84] and 63% [61, 65] would enroll in 2-week and 6 month AC studies; 77% [74, 80] of 551 taking inhABX would enroll in a 2-week PC inhABX study versus 59% [55, 63] for a 6-month study. Previous clinical trial experience increased willingness. Study designs will affect feasibility of future clinical trials of new modulators and inhABX in people receiving ETI. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
15691993
Volume :
22
Issue :
4
Database :
Academic Search Index
Journal :
Journal of Cystic Fibrosis
Publication Type :
Academic Journal
Accession number :
171586478
Full Text :
https://doi.org/10.1016/j.jcf.2023.04.007