Vertex VX20-445-118

Details

CTAP badge
Therapeutic approach
Observational
Trial status
Recruitment complete Participating Centres
Trials Tracker ID
TT006271
Last updated
12/02/2021

Full title

A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor

Study details

This study is being carried out to learn more about the information that wearable technology can give us on physical activity, cough frequency and sleep quality in people with cystic fibrosis (CF). All visits in this study are home based and will be conducted via telemedicine video conference via a mobile app.

Study participation will last about 16 weeks: after a 4-week screening period with one remote study visit, there will be 12 further remote visits over the remaining 12-week study period. Throughout this study participants will continue their usual activity and treatment regime.

The study involves the participant wearing an activity monitor on their wrist for the 12-week study period. A cough monitor will be worn for 24 continuous hours once a week during the study period, and a 7-day activity and cough diary at four different times in the study will need to be completed. Participants will also answer questions about their health, medical history and medication from the study doctor; complete a questionnaire on quality of life and CF symptoms, and fill out a feedback survey at the end of the study


Phase
Phase 4
Length of participation
16 weeks
Recruitment target
0
CF sponsor
Vertex Pharmaceuticals Incorporated

Who can take part?

Age range
18 years and older
Including people

Forced expiratory volume in 1 second (FEV1) value greater than or equal to (≥) 30 percent predicted
Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels

Excluding people

History of solid organ or hematological transplantation
Non-ambulatory status

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CF centres running this trial

Closed

Birmingham Heartlands Hospital (Adults)

CTAP centre
NHS Trust
University Hospitals Birmingham NHS Foundation Trust
Address
Bordesley Green
B9 5SS
Local site investigator
Joanna Whitehouse
Trial Coordinators
Aoife Neal
Closed

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Local site investigator
Nicholas Simmonds
Trial Coordinators
Sophie Pinnell
Closed

Royal Devon & Exeter Hospital

CTAP centre
NHS Trust
The Royal Devon & Exeter NHS Foundation Trust
Address
Barrack Road
EX2 5DW
Local site investigator
Nick Withers
Trial Coordinators
Sophie Whiteley
Closed

Southampton General Hospital

CTAP centre
NHS Trust
University Hospital Southampton NHS Foundation Trust
Address
Tremona Road
SO16 6YD
Local site investigator
Mary Carroll
Trial Coordinators
Matthew Harvey
Closed

St James's University Hospital - Leeds (Adults)

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Local site investigator
Daniel Peckham
Trial Coordinators
Helen Chadwick