Trials / Completed
CompletedNCT02871778
Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia
A Phase 2a, 2-part,Randomized, Double-blind, Placebo-controlled, Incomplete Block Crossover Study to Evaluate the Safety and Efficacy of VX-371 Solution for Inhalation With and Without Oral Ivacaftor in Subjects With Primary Ciliary Dyskinesia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 123 (actual)
- Sponsor
- Parion Sciences · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-371 | |
| DRUG | Hypertonic Saline | |
| DRUG | Placebo (0.17% saline) | |
| DRUG | VX-371 + HS | |
| DRUG | Ivacaftor |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-11-20
- Completion
- 2018-11-20
- First posted
- 2016-08-18
- Last updated
- 2021-12-16
- Results posted
- 2021-12-16
Locations
34 sites across 8 countries: United States, Canada, Denmark, Germany, Italy, Netherlands, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02871778. Inclusion in this directory is not an endorsement.