drugset / Trial / NCT02823470
A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.
Timeline
- Start
- 2016-06
- Primary completion
- 2017-08
- Completion
- 2017-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Ivacaftor | Other / unclassified | 250 mg | — |
| Background | Lumacaftor | Small molecule | 400 mg | — |