- Therapeutic approach
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- Last updated
A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/IvacaftorStudy 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 4
- Length of participation
- 16 weeks
- Recruitment target
- 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