Adherence to LUM and IVA in CF
Research type
Research Study
Full title
A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation
IRAS ID
214042
Contact name
Gordon MacGregor
Contact email
Sponsor organisation
Vertex Pharmaceuticals
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 17 days
Research summary
This is a phase IV, Open-label, randomised study to monitor adherence to Lumacaftor(LUM)/Ivacaftor(IVA) in Cystic Fibrosis patients.
The purpose of the study is to learn more about the use of Smart Adherence Technology (smart pill bottles) in patients with Cystic Fibrosis while taking LUM/IVA combination treatment.
About 75 people will participate in the study. Eligible patients will receive LUM and IVA, which has been approved for the treatment of CF by the MHRA. Patients will be randomly assigned to receive either an activated smart pill bottle or a control smart pill bottle, which will be de-activated. Patients will remain in the study for 48 weeks.
The smart pill bottles offer a method for CF patients and physicians to objectively monitor medication compliance and to make long-term adherence manageable. Studies have shown that 30-50% of medicines are not taken as recommended and adherence tends to decline after the first 6 months of treatment.
A number of safety assessments and procedures will be performed during the study including physical examinations, blood sample assessments, patient compliance questionnaires and pregnancy tests (if applicable).
The study will be run at approximately 8 to 10 centres in the UK and is sponsored by Vertex Pharmaceuticals Limited.
REC name
West of Scotland REC 5
REC reference
16/WS/0257
Date of REC Opinion
20 Dec 2016
REC opinion
Unfavourable Opinion