Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03435939
• Date of registration: 05/02/2018
• Prospective Registration: Yes
• Primary sponsor: University of Kansas Medical Center
• Public title: Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
• Scientific title: Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients
• Date of first enrolment: February 15, 2022
• Target sample size: 16
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03435939
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Matthias Salathe, MD

• Name: Matthias Salathe, MD
• Affiliation: University of Kansas

• Name: Matthias Salathe, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- CF patients with any known mutation combination not on CFTR augmentation therapy

- =18 years of age

- Severity of the Disease: Suitable patients will have mild to moderate lung disease, as
defined by:

- Pulmonary Function: Each patient must have an FEV1 =40% of predicted at the
screening visit.

- Hemoglobin saturation: Patients must have an oxygen saturation of >92% on room
air as determined by pulse oximetry at the screening visit.

- Produces sputum regularly (daily basis, at minimum)

- FEV1 = 40% of predicted at screening visit

- Able to sign Informed consent

- Negative COVID-19 test within 72 hours prior to MCC testing

Exclusion Criteria:

- When enrolling female patients

- Not willing to adhere to strict birth control (combination of two methods)

- If female, patient must be non-pregnant and non-lactating, and those of childbearing
potential must be using an acceptable method of birth control (i.e., an Intrauterine
Contraceptive Device with a failure rate of <1%, hormonal contraceptives or a barrier
method). If a female patient is abstinent, she must agree to use one of the acceptable
methods if she becomes sexually active.

- Unstable lung disease: As defined by a change in medical regimen during the preceding
2 weeks or an FEV1 =15% below value within 3 months

- Received an investigational drug or therapy during the preceding 30 days

- Active or former smokers with less than 1 year since quitting, or >10 pack-year
smoking history

- Unable to adequately complete study measures, including spirometry

- Intolerance to angiotensin receptor blockers (ARB)

- Treatment with angiotensin converting enzyme (ACE) inhibitor

- Regular use of NSAIDs or potassium supplementation, treatment with aliskiren, on
anticoagulation

- Oral corticosteroid use within 6 weeks

- Exacerbation requiring treatment within 6 weeks

- Treatment of mycobacterial infections

- Significant hypoxemia (oxygen saturation <92% on room air and rest or use of
continuous oxygen treatment), chronic respiratory failure by history (pCO2 > 45 mmHg),
clinical evidence of cor pulmonale

- Untreated arterial hypertension (systolic blood pressure >140 mm Hg, diastolic blood
pressure > 90 mmHg)

- Blood pressure less than 90 mm Hg systolic while standing

- Cardiac, renal (creatinine 1.5 times normal limit), hepatic (LFTs > 3x normal upper
limit), neurological, psychiatric, endocrine or neoplastic diseases that are judged to
interfere with participation in study

- Known renal artery stenosis

- Concomitant airway disorders other than CF, such as ABPA

- Subjects with prior thoracic surgery

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or may
interfere with the interpretation of trial results and, in the judgment of the PI,
would make the subject inappropriate for enrollment.

- Patients using intermittent inhaled or oral antibiotics will be allowed to participate
in this trial. Patients on chronic, cycling antibiotics will be required to have
completed at least 2 full cycles of the prescribed antibiotic prior to enrollment and
should be studied during the same phase of treatment (on or off) during each study
period.

- Have had radiation exposure within the past year that would cause them to exceed
Federal Regulations by participating in this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Losartan

Primary Outcome(s)

Improvement of mucociliary clearance ( MCC) and cough clearance (CC) [Time Frame: 12 weeks treatment]

Secondary Outcome(s)

Nasal cytokine changes [Time Frame: 12 weeks]

Improvement on pulmonary function tests (in %predicted) [Time Frame: 12 weeks of treatment]

Improvement on pulmonary function tests (in L) [Time Frame: 12 weeks of treatment]

Decrease of inflammatory markers [Time Frame: 12 weeks]

Secondary ID(s)

20170522

Source(s) of Monetary Support

Please refer to primary and secondary sponsors