Phase 3
N=82
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04969224 ↗Enrolled (actual)
82
Serious AEs
2.5%
Results posted
Oct 2023
Primary outcome: Primary: Percent Reduction From Baseline in Cough Frequency (Cough Events Per Day) to the Average of Week 8 Through Week 12 — 91.7 percent reduction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ELX/TEZ/IVA (Drug); IVA (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction From Baseline in Cough Frequency (Cough Events Per Day) to the Average of Week 8 Through Week 12 |
91.7 | — |
| SECONDARY Absolute Change From Baseline in Total Step Count Per Day to the Average of Week 8 Through Week 12 |
637.56 | — |
Summary
This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.
Eligibility Criteria
Key Inclusion Criteria
- Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted
- Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation and a minimal function mutation (F/MF genotypes)
Key Exclusion Criteria
- Clinically significant liver cirrhosis
- Solid organ or hematological transplantation
- Non-ambulatory status
- Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04969224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.