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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05599230

Enrollment

Registered

2022-10-31

Start date

2022-09-01

Completion date

2022-11-30

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

elexacaftor, time course, FEV1, Respiratory symptoms

Brief 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.

Interventions

DRUGElexacaftor 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Inclusion criteria

* Cystic fibrosis diagnosis * At least 12 years old * Carrier of at least one copy of F508del mutation * Ability to perform reliable and reproducible spirometry * Medical and psychological stability * written consent * owning a smartphone

Exclusion criteria

* Lung transplant * FEV1 \> 120 % pr (%GLI) at the inclusion test * Pulmonary exacerbation

Design outcomes

Primary

Measure	Time frame	Description
FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI	17 days	Daily home spirometry with Spirobank device, between 14H-20H, before nebulization and / or physiotherapy

Secondary

Measure	Time frame	Description
Respiratory symptoms score changes from baseline (3 days before treatment) to Day 14 under ETI	17 days	Daily scoring unsing a respiratory questionnaire (8 questions); each item is scored 1 to 5 (worse score: 40)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026