NCT05599230

Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: CHC Montlegia · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to provide optimal monitoring and support when initiating ETI treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) FEV1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. Through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening	Patients will daily perform home spirometry and complete a respiratory symptoms score before (3 days) and during (first 14 days) ETI treatment.

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-10-31
• Last updated: 2022-10-31

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study