Losartan and Inflammation in Cystic Fibrosis

University of Miami

Status and phase: Terminated; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Losartan; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03206788

20170397

20170333 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7 participants in 2 patient groups, including a placebo group

Losartan group

Experimental group

Description:

Participant will receive the Losartan intervention and will take 50 mg losartan orally once daily for week 1, followed by 50 mg orally twice daily on weeks 2-12 (unless weight adjustment needed).

Treatment:

Drug: Losartan

Placebo group

Placebo Comparator group

Description:

Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.

Treatment:

Drug: placebo