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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364176
• Other study ID #: STUDY00149479
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: Heidi Hellwig
• Phone: 9135886045
• Email: hhellwig[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: October 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation

Intervention

Drug:
• Losartan
Treatment with losartan through week 12
• Placebo
Treatment with placebo through week 12

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sweat chloride	Change in sweat chloride concentration	Baseline through week 12
Secondary	Lung function - absolute	Absolute change in percent predicted forced expiratory volume in one second (ppFEV1)	Baseline through week 12
Secondary	Lung function - relative	Relative change in ppFEV1	Baseline through week 12
Secondary	Transforming growth factor (TGF)-beta1 - airway	Change in nasal fluid levels of TGF-beta1	Baseline through week 12
Secondary	TGF-beta1 - systemic	Change in plasma levels of TGF-beta1	Baseline through week 12
Secondary	Inflammatory mediators - airway	Change in concentration nasal fluid levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)	Baseline through week 12
Secondary	Inflammatory mediators - systemic	Change in plasma levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)	Baseline through week 12
Secondary	CFQ-R	Change in CF questionnaire revised (CFQ-R); scale 0-100 with higher scores indicating better quality of life	Baseline through week 12
Secondary	Adverse events	Cumulative incidence of adverse events	Baseline through week 12