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

Vertex Pharmaceuticals

Status: Completed

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04923464

VX20-445-118

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

51 participants in 1 patient group

ELX/TEZ/IVA

Description:

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.