Trial record 1 of 1 for:
PS-G201
Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF) (CLEAN-CF)
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| ClinicalTrials.gov Identifier: NCT02343445 |
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Recruitment Status :
Completed
First Posted : January 22, 2015
Last Update Posted : July 26, 2021
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Sponsor:
Parion Sciences
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Parion Sciences
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: P-1037 Drug: Hypertonic Saline Drug: Saline | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 142 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF) |
| Study Start Date : | April 2015 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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Drug: P-1037
P-1037 is a novel ENaC inhibitor Drug: Hypertonic Saline 4.2% saline solution |
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Experimental: P-1037 in Saline
P-1037 Solution for Inhalation, 85 μg BID (28.3 μg/mL) in 0.17% saline BID
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Drug: P-1037
P-1037 is a novel ENaC inhibitor Drug: Saline 0.17% saline solution |
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Placebo Comparator: Saline
Placebo (0.17% saline) BID
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Drug: Saline
0.17% saline solution |
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Sham Comparator: Hypertonic Saline
Hypertonic saline (4.2% saline) BID
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Drug: Hypertonic Saline
4.2% saline solution |
Primary Outcome Measures :
- Safety (number of adverse events of P-1037 in treatment groups) [ Time Frame: Day 15 ]number of adverse events of P-1037 in treatment groups
- Safety [change in forced expiratory volume in one second (FEV1) from predosing to 1 hour post dosing] [ Time Frame: Day 1 ]change in FEV1 from predosing to 1 hour post dosing with P-1037 in 4.2 % hypertonic saline and P-1037 in 0.17% saline
Secondary Outcome Measures :
- Absolute change in FEV1 [ Time Frame: Day 15 ]change in FEV1, from baseline (immediately before first dose) to same time of day on Day 15
- Effect of P-1037 on other forced vital capacity (FVC) measures (change in FVC from baseline (immediately before first dose) to same time of day on Day 15) [ Time Frame: Day 15 ]change in FVC from baseline (immediately before first dose) to same time of day on Day 15
- Effect of P-1037 on Cystic Fibrosis Questionnaire - Revised (CFQ-R) [ Time Frame: Day 15 ]CFQ-R on Day 15
- Determine whether co-administration of hypertonic saline (HS) enhances the effect of P-1037 on FEV1 (FEV1 on Day 15) [ Time Frame: Day 15 ]FEV1 on Day 15
- Effect of P-1037 on (forced expiratory flow at 25%-75% of vital capacity (FEF25-75%) [ Time Frame: Day 15 ]FEF25-75% from baseline (immediately before first dose) to same time of day on Day 15
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| Ages Eligible for Study: | 12 Years to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343445
Locations
Show 33 study locations
Sponsors and Collaborators
Parion Sciences
Vertex Pharmaceuticals Incorporated
Investigators
| Study Chair: | Karl Donn | Parion Sciences |
| Responsible Party: | Parion Sciences |
| ClinicalTrials.gov Identifier: | NCT02343445 |
| Other Study ID Numbers: |
PS-G201 |
| First Posted: | January 22, 2015 Key Record Dates |
| Last Update Posted: | July 26, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |