A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923464
• Other study ID #: VX20-445-118
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• History of solid organ or hematological transplantation

• Non-ambulatory status

Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	St. James University Hospital	Leeds
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital	London
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Southampton General Hospital	Southampton
United States	Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center	Boston	Massachusetts
United States	National Jewish Health	Denver	Colorado
United States	UW School of Medicine & Public Health	Madison	Wisconsin
United States	Morristown Medical Center	Morristown	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Mount Sinai Beth Israel	New York	New York
United States	Santiago Reyes, M.D.	Oklahoma City	Oklahoma
United States	Central Florida Pulmonary Group, P.A.	Orlando	Florida
United States	Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center	Peoria	Illinois
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device		From Day 1 up to Week 12
Secondary	Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device		From Day 1 up to Week 12
Secondary	Number of Steps per day and Variability in Number of Steps per day Over Time	Number of steps will be reported as mean and variability will be reported as standard deviation (SD).	From Day 1 up to Week 12
Secondary	Number of Coughs per day and Variability in Number of Coughs per day Over Time	Number of coughs will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time	Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Time Spent in Moderate-to-Vigorous Physical Activity per day and Variability in Time Spent in Moderate-to-Vigorous Physical Activity per day Over Time	Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time	Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Total Activity Count per day and Variability in Total Activity Count per day Over Time	Total activity count will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time	B6ME will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12
Secondary	Sleep Efficiency and Variability in Sleep Efficiency Over Time	Sleep efficiency measurements will be performed using wearable technology which include a wrist-worn actigraphy sensor. Sleep efficiency will be reported as mean and variability will be reported as SD.	From Day 1 up to Week 12