Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2017-11-11
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>12 years
* Forced expiratory volume at one second (FEV1) \>/= 40% of predicted
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Kansas Medical Center
OTHER
Cystic Fibrosis Foundation
OTHER
University of Miami
OTHER
Responsible Party
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Matthias Salathe
Emeritus Professor
Principal Investigators
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Matthias Salathe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
University of Kansas
Kansas City, Kansas, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20170333
Identifier Type: OTHER
Identifier Source: secondary_id
20170397
Identifier Type: -
Identifier Source: org_study_id