Conditions: Cystic Fibrosis Advanced Lung Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation

Detailed description:

Arms:
arm 1: Lumacaftor 400 milligram (mg) and ivacaftor 250 mg combination tablet orally twice daily for 24 weeks.

Interventions: intervention 1: Lumacaftor intervention 2: Ivacaftor
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: