Losartan and Inflammation in Cystic Fibrosis

• Status: Terminated
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the University of Miami, Cincinnati Children's Medical Hospital Center, University of Kansas Medical Center and University of Alabama-Birmingham.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborators: Children's Hospital Medical Center, Cincinnati; Cystic Fibrosis Foundation; University of Alabama at Birmingham; University of Kansas Medical Center
• Treatments: Losartan

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