drugset / Trial / NCT02709109
A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi
Timeline
- Start
- 2016-02
- Primary completion
- 2017-09
- Completion
- 2017-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IDREVLORIDE | Small molecule | 85 ug | Inhaled |
| Background | Hypertonic saline | Unknown | 3 ml | Inhaled |
| Background | Ivacaftor | Other / unclassified | 2 unknown | Oral |