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NCT05599230 Clinical Trial

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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05599230
Other study ID # ML001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date November 30, 2022

Study information
Verified date October 2022
Source CHC Montlegia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Belgium Lebecque Liège

Sponsors (1)
Lead Sponsor Collaborator
CHC Montlegia

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI Daily home spirometry with Spirobank device, between 14H-20H, before nebulization and / or physiotherapy 17 days
Secondary Respiratory symptoms score changes from baseline (3 days before treatment) to Day 14 under ETI Daily scoring unsing a respiratory questionnaire (8 questions); each item is scored 1 to 5 (worse score: 40) 17 days
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