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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: activated smart device alerts and feedback

LUM/IVA: LUM 400 mg q12h/IVA 250 mg q12h through Week 48.

Group Type EXPERIMENTAL

LUM/IVA

Intervention Type DRUG

LUM 400 mg q12h/IVA 250 mg q12h through Week 48.

activated smart device

Intervention Type DEVICE

Arm B: de-activated smart device alerts/feedback features

LUM/IVA: LUM 400 mg q12h/IVA 250 mg q12h through Week 48.

Group Type EXPERIMENTAL

LUM/IVA

Intervention Type DRUG

LUM 400 mg q12h/IVA 250 mg q12h through Week 48.

de-activated smart device

Intervention Type DEVICE

Interventions

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LUM/IVA

LUM 400 mg q12h/IVA 250 mg q12h through Week 48.

Intervention Type DRUG

activated smart device

Intervention Type DEVICE

de-activated smart device

Intervention Type DEVICE

Other Intervention Names

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lumacaftor/ivacaftor

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No