Status:
WITHDRAWN
Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis
Lead Sponsor:
Universidad Europea de Madrid
Conditions:
Cystic Fibrosis in Children
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
This study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young ...
Detailed Description
The present study is a new clinical trial that extends our previous work intended to assess the effect of programmed exercise with or without electrical stimulation on cardiorespiratory fitness, stren...
Eligibility Criteria
Inclusion
- In order to be included, patients must have participated in the ECOMIRIN clinical trial (ClinicalTrials.gov Identifier: NCT04153669).
- They must have a previous CF diagnosis, defined as: sweat chlorine ≥ 60 mEq/L and/or carry two variants of the CFTR gene characterized as pathogenic.
- Age 6-18 years; eligible to receive treatment with TEZ/IVA or LUM/IVA according to the AEMPS (LUM/IVA for 6-11 year-old children homozygous for the F508del mutation; TEZ/IVA for ≥ 12 year-old children homozygous for the Phe508del mutation, as well as heterozygous for the F508 mutation plus one of the following mutations: P67L, R117C, L206W, R352Q, A455E, D579G, 711 + 3A G, S945L, S977F, R1070W, D1152H, 2789 + 5G A, 3272-26A G, and 3849 + 10kbC T);
- Agreement to collaborate in performing static and dynamic pulmonary function tests.
- Consent of children and/or parents or legal guardians to participate in the study after having read and understood the informed consent form.
Exclusion
- CF patients not consenting to participate in the study at any time after reading and understanding the informed consent form will be excluded.
- CF patients who are not eligible to receive treatment with TEZ/IVA or LUM/IVA according to the AEMPS during the course of the study will be excluded.
- Study participants will be excluded if they test positive for any contagious viral infection that may affect the outcomes (e.g. SARS-CoV-2).
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04415268
Start Date
June 9 2020
End Date
May 15 2021
Last Update
December 11 2023
Active Locations (1)
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1
Escuela de Doctorado e Investigacion, Universidad Europea
Villaviciosa de Odón, Spain, 28670