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

NCT ID: NCT05599230

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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Cystic Fibrosis

Keywords

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elexacaftor time course FEV1 Respiratory symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CF patients before (3 days) and during (14 days) ETI treatment

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

Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening

Intervention Type DRUG

Patients will daily perform home spirometry and complete a respiratory symptoms score before (3 days) and during (first 14 days) ETI treatment.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHC Montlegia

OTHER

Sponsor Role lead

Responsible Party

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Lebecque Patrick

Principal investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Lebecque, PhD

Role: PRINCIPAL_INVESTIGATOR

CHC Montlegia

Locations

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Lebecque

Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML001

Identifier Type: -

Identifier Source: org_study_id