The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGSweat chloride
Change in sweat chloride concentration
Time frame: Baseline through week 12
Lung function - absolute
Absolute change in percent predicted forced expiratory volume in one second (ppFEV1)
Time frame: Baseline through week 12
Lung function - relative
Relative change in ppFEV1
Time frame: Baseline through week 12
Transforming growth factor (TGF)-beta1 - airway
Change in nasal fluid levels of TGF-beta1
Time frame: Baseline through week 12
TGF-beta1 - systemic
Change in plasma levels of TGF-beta1
Time frame: Baseline through week 12
Inflammatory mediators - airway
Change in concentration nasal fluid levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Time frame: Baseline through week 12
Inflammatory mediators - systemic
Change in plasma levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Time frame: Baseline through week 12
CFQ-R
Change in CF questionnaire revised (CFQ-R); scale 0-100 with higher scores indicating better quality of life
Time frame: Baseline through week 12
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Adverse events
Cumulative incidence of adverse events
Time frame: Baseline through week 12