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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ELX/TEZ/IVA<br>CF participants who are currently on a stable regimen of commercially available ELX/TEZ/IVA will be evaluated for the performance of wearable technology devices. Wearable devices include a wrist-worn actigraphy sensor and an ambulatory cough monitoring system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |