Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
Public ClinicalTrials.gov record NCT02343445. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02343445
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2015
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
- Last update posted
- Jul 25, 2021
2015 – 2016
United States locations
- U.S. sites
- 33
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Univ of Florida Dept of Medicine | Gainesville | Florida | 32610 | — |
| University of Miami Adult CF Center | Miami | Florida | 33136 | — |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | — |
| New Lung Associates | Tampa | Florida | 33606 | — |
| Chicago Cystic Fibrosis Institute | Glenview | Illinois | 60025 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| UMass Memorial medical Center | Worcester | Massachusetts | 01655 | — |
| Wayne State University/Harper University Hospital | Detroit | Michigan | 48201 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Rutgets-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Pediatric Pulmonology/Cystic Fibrosis | Somerville | New Jersey | 08876 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11042 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27517 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Toledo Hospital | Toledo | Ohio | 43606 | — |
| Santiago Reyes | Oklahoma City | Oklahoma | 73112 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Anderson Pharmaceutical Research | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | — |
| Univ of Texas Health Science Center | Tyler | Texas | 75708 | — |
| University of Virginia Childrens | Charlottesville | Virginia | 22908 | — |
| University of Wisconsin UW Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02343445, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2021 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02343445 live on ClinicalTrials.gov.