This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Fixed dose combination (FDC) tablet for oral administration.
Tablet for oral administration.
Royal Adelaide Hospital
Adelaide, Australia
The Prince Charles Hospital
Chermside, Australia
Percent Reduction From Baseline in Cough Frequency (Cough Events Per Day) to the Average of Week 8 Through Week 12
Percent reduction in cough frequency was analyzed with a mixed effects model for repeated measures (MMRM), with change from baseline at each post-baseline visit on the natural log scale as the dependent variable. The percent reduction was estimated as 100% × (1-exponential form of LS mean change estimate from the MMRM).
Time frame: Baseline, Week 8 through Week 12
Absolute Change From Baseline in Total Step Count Per Day to the Average of Week 8 Through Week 12
Time frame: Baseline, Week 8 through Week 12
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Alfred Hospital
Melbourne, VIC, Australia
Institute for Respiratory Health
Nedlands, Australia
Telethon Kids Institute
Nedlands, Australia
The Royal Children's Hospital
Parkville, VIC, Australia
Mater Adult Hospital
South Brisbane, Australia
Queensland Children's Hospital
South Brisbane, Australia
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, Belgium
...and 9 more locations