Study terminated early due to slow recruitment of patients.

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.

Inclusion Criteria:

• Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF).
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
• Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation
• Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted normal for age, sex, and height

Exclusion Criteria:

• Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C)
• Subjects currently receiving invasive mechanical ventilation
• Known history of alcohol or drug abuse in the past year
• Clinically significant abnormal laboratory values during screening
• Pregnant or nursing females
• Female subjects and female partners of male subjects who plan to become pregnant during Treatment Period or within 90 days following the last dose of study drug
• History of solid organ or hematological transplantation
• Ongoing or prior participation in an investigational drug study within 30 days of screening
• Current use of commercial LUM/IVA combination therapy

PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.