Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

Description

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.

Conditions

Cystic Fibrosis

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Study Overview

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Study Details

Study overview

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.

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Established diagnosis of cystic fibrosis
  • * Age 12 years and older
  • * Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
  • * Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
  • * Prior lung transplant
  • * BMI \<18
  • * CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
  • * Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
  • * Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
  • * Concomitant use of medications known to interact with losartan, including aliskiren
  • * Chronic renal insufficiency (creatinine clearance \<45 ml/min)
  • * Pregnancy or lactation
  • * Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
  • * In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment
  • * Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Kansas Medical Center,

Charles Bengtson, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

2027-10