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

October 25, 2022 updated by: Lebecque Patrick, CHC MontLégia
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Lebecque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CF patients aged 12 y or more, carrying at least one copy of F508del mutation, in stable condition, reliably performing spirometry

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHC MontLégia

Investigators

  • Principal Investigator: Patrick Lebecque, PhD, CHC MontLégia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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