Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
NCT ID: NCT02343445
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2015-04-30
2016-02-29
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
QUADRUPLE
Study Groups
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P-1037 in Hypertonic Saline (HS)
P-1037 Solution for Inhalation, 85 μg twice daily (BID) (28.3 μg/mL) in hypertonic saline (4.2% saline) BID
P-1037
P-1037 is a novel ENaC inhibitor
Hypertonic Saline
4.2% saline solution
P-1037 in Saline
P-1037 Solution for Inhalation, 85 μg BID (28.3 μg/mL) in 0.17% saline BID
P-1037
P-1037 is a novel ENaC inhibitor
Saline
0.17% saline solution
Saline
Placebo (0.17% saline) BID
Saline
0.17% saline solution
Hypertonic Saline
Hypertonic saline (4.2% saline) BID
Hypertonic Saline
4.2% saline solution
Interventions
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P-1037
P-1037 is a novel ENaC inhibitor
Hypertonic Saline
4.2% saline solution
Saline
0.17% saline solution
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cystic fibrosis as determined by the 1997 CF Consensus criteria (NIH Consensus Statement, 1997)
* Non-smoker
* FEV1 at Screening Visit 1 between 40% and 90%
* Stable regimen of CF medications and chest physiotherapy for the 28 days prior to Screening. Must be willing to discontinue use of hypertonic saline for the duration of the study.
* Clinically stable for at least 2 weeks
* All females of child-bearing potential must have a negative serum pregnancy test and if sexually active must agree to practice a highly effective form of contraception throughout the study and for 28 days after the last dose of study medication.
Exclusion Criteria
* Use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs or trimethoprim in the 28 days prior to Screening
* History of significant intolerance to inhaled hypertonic saline, as determined by the Investigator
* Known hypersensitivity to the study drug or amiloride
* Any clinically significant laboratory abnormalities at Screening Visit 1 as judged by the investigator, or any of the following:
* Potassium ≥ 5 milliequivalent per Liter (mEq/L)
* Abnormal renal function
* Abnormal liver function, defined as ≥ 3 x upper limit of normal (ULN)
* Hemoglobin level \< 10.0 g/dL
* Female who is pregnant or lactating
* History of sputum or throat swab culture yielding Burkholderia species or Mycobacterium abscessus within 2 years of screening
* Has previously participated in an investigational trial involving administration of any investigational compound or use of an investigational device with 28 days prior to Screening
* Currently being treated with any ivacaftor containing regimen
12 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Parion Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Karl Donn
Role: STUDY_CHAIR
Parion Sciences
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Univ of Florida Dept of Medicine
Gainesville, Florida, United States
University of Miami Adult CF Center
Miami, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
New Lung Associates
Tampa, Florida, United States
Chicago Cystic Fibrosis Institute
Glenview, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
UMass Memorial medical Center
Worcester, Massachusetts, United States
Wayne State University/Harper University Hospital
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgets-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Pediatric Pulmonology/Cystic Fibrosis
Somerville, New Jersey, United States
Albany Medical College
Albany, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Santiago Reyes
Oklahoma City, Oklahoma, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Anderson Pharmaceutical Research
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Children's Chest Associates
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
Univ of Texas Health Science Center
Tyler, Texas, United States
University of Virginia Childrens
Charlottesville, Virginia, United States
University of Wisconsin UW Hospital
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PS-G201
Identifier Type: -
Identifier Source: org_study_id
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