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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Losartan group 		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).
  • Drug: Losartan
    25 mg or 50 mg (based on patient's weight) Losartan tablets taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
    Other names:
    • Cozaar
Placebo Comparator
Placebo group 		Participant will receive the placebo intervention, matching the Losartan intervention, once daily for week 1, followed by twice daily on weeks 2-12.
  • Drug: placebo
    Placebo tablets, matching the Losartan intervention, taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
    Other names:
    • matching placebo twice daily

More Details

Status
Terminated
Sponsor
University of Miami

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.