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

Active, not recruiting

• Conditions: Cystic Fibrosis
• Interventions: Drug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening

• Registration Number: NCT05599230
• Lead Sponsor: CHC Montlegia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CF patients before (3 days) and during (14 days) ETI treatment	Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening	Patients over 12 years old and eligible will start ETI treatment ( current standart treatment). * Morning: Elexacaftor 100 mg, Tezacaftor 50 mg, Ivacaftor 75 mg, 2 tablets * Evening: Ivacaftor 150 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Lebecque; 🇧🇪 Liège, Belgium