Losartan and Inflammation in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03206788
• Date of registration: 29/06/2017
• Prospective Registration: Yes
• Primary sponsor: University of Miami
• Public title: Losartan and Inflammation in Cystic Fibrosis
• Scientific title: Losartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) Recovery
• Date of first enrolment: November 11, 2017
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03206788
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- CF patients homozygous for F508del and on current treatment with Orkambi™ for at least
3 months

- Age >12 years

- Forced expiratory volume at one second (FEV1) >/= 40% of predicted

Exclusion Criteria:

- Female patients not willing to adhere to strict birth control (combination of two
methods)

- Pregnancy

- History of intolerance to angiotensin receptor blockers (ARBs)

- Treatment with angiotensin converting enzyme (ACE) inhibitor

- NPD response to zero chloride (0Cl)/isoproterenol of > - 6.6 mV at screening (evidence
of detectable CFTR activity at baseline)

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

- Oral corticosteroid use within 6 weeks

- Exacerbation requiring treatment within 6 weeks

- Active treatment for mycobacterial infections

- Significant hypoxemia (oxygen saturation <90% 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 allergic bronchopulmonary
aspergillosis (ABPA).

- Subjects with prior thoracic surgery



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Losartan

Drug: placebo

Primary Outcome(s)

Change in Nasal Potential Difference (NPD) to Assess CFTR Activity [Time Frame: Baseline, 12 weeks]

Secondary Outcome(s)

Change in Cytokine Levels [Time Frame: Baseline, 12 weeks]

Change in GM-CSF Values [Time Frame: Baseline, 12 weeks]

Change in mRNA Expression [Time Frame: Baseline, 12 weeks]

Change in NPD to Assess CaCC Activity [Time Frame: Baseline, 12 weeks]

Change in Sweat Chloride Concentration [Time Frame: Baseline, 12 weeks]

Change in %PMN Values [Time Frame: Baseline, 12 weeks]

Change in SAA Values [Time Frame: Baseline, 12 weeks]

Change in FEV1 [Time Frame: Baseline, 12 weeks]

Change in Quality of Life (QoL) Scores as Assessed by the CFQ-R [Time Frame: Baseline, 12 weeks]

Change in Calprotectin Values [Time Frame: Baseline, 12 weeks]

Change in Losartan Metabolites Levels [Time Frame: Baseline, 12 weeks]

Change in hsCRP [Time Frame: Baseline, 12 weeks]

Change in NPD to Assess BK Activity [Time Frame: Baseline, 12 weeks]

Change in TGF-beta Values [Time Frame: Baseline, 12 weeks]

Change in Blood Count Values [Time Frame: Baseline, 12 weeks]

Secondary ID(s)

20170397

20170333

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Alabama at Birmingham

University of Kansas Medical Center

Children's Hospital Medical Center, Cincinnati

Cystic Fibrosis Foundation

Results

• Results available: Yes
• Date Posted: 13/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03206788