Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)

Completed · Phase 2

Conditions studied: Cystic Fibrosis

In brief

The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect on lung function in patients with CF than placebo (0.17% saline).

Key facts

Study ID

NCT02343445

Run by

Parion Sciences

People needed

142

Starts

2015-04-01

Expected to finish

2016-02-01

Last updated by the study team

2021-07-26

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 12 years of age or older.
• 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.

You may not qualify if…

• History of any organ transplantation or any significant disease or disorder
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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