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

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

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.

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