Trials / Completed
CompletedNCT02343445
Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Parion Sciences · Industry
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | P-1037 | P-1037 is a novel ENaC inhibitor |
| DRUG | Hypertonic Saline | 4.2% saline solution |
| DRUG | Saline | 0.17% saline solution |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2015-01-22
- Last updated
- 2021-07-26
Locations
33 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02343445. Inclusion in this directory is not an endorsement.