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Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis

NCT04415268 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-11

No results posted yet for this study

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 patients with Cystic Fibrosis.

Conditions

  • Cystic Fibrosis in Children

Interventions

BEHAVIORAL

Exercise

Surpervised exercise program: Includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions.

BEHAVIORAL

Unsupervised exercise

Unsupervised exercise program: The same exercise program learned during the supervised phase will be practiced at home.

DRUG

CFTR Modulators

Standard of care: Lumacaftor with Ivacaftor or Tezacaftor combined with Ivacaftor. For children between 6 and 11 years of age, Lumacaftor 400 mg combined with Ivacaftor 500 mg in total per day, divided into 2 doses per day; for those over 11 years of age, Tezacaftor 100 mg combined with Ivacaftor 150 mg in the morning, adding a dose of Ivacaftor 150 mg at night. https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/ES

Sponsors & Collaborators

  • Universidad Europea de Madrid

    lead OTHER

Principal Investigators

  • Margarita Perez-Ruiz, MD · Universidad Politecnica de Madrid

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2021-01-29
Completion
2021-05-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415268 on ClinicalTrials.gov