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Cystic Fibrosis clinical trials

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NCT ID: NCT06371261 Recruiting - Cystic Fibrosis Clinical Trials

Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis

ACHROMO-MUCO
Start date: February 29, 2024
Phase:
Study type: Observational

The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation (Tetart et al. 2019, Somayaji et al. 2017, Recio et al. 2018), making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned. However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification. In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation.

NCT ID: NCT06350149 Recruiting - Cystic Fibrosis Clinical Trials

A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis

Start date: March 22, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: - Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. - What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.

NCT ID: NCT06339593 Recruiting - Cystic Fibrosis Clinical Trials

Regional Monitoring of CF Lung Disease

Start date: January 5, 2024
Phase:
Study type: Observational

The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.

NCT ID: NCT06322446 Recruiting - Cystic Fibrosis Clinical Trials

Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy

FIQMODE
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.

NCT ID: NCT06312787 Recruiting - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation

Start date: April 2, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants.

NCT ID: NCT06311292 Recruiting - Cystic Fibrosis Clinical Trials

Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Start date: April 2024
Phase: N/A
Study type: Interventional

This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum. Participants will use the Volara System during clinic visit in an attempt to produce sputum.

NCT ID: NCT06306508 Recruiting - Cystic Fibrosis Clinical Trials

Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis

Start date: February 16, 2024
Phase:
Study type: Observational [Patient Registry]

Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.

NCT ID: NCT06302270 Recruiting - Cystic Fibrosis Clinical Trials

CFTR Modulators in Pregnancy and Postpartum

Start date: March 15, 2024
Phase:
Study type: Observational

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

NCT ID: NCT06299709 Recruiting - Cystic Fibrosis Clinical Trials

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

Start date: March 13, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

NCT ID: NCT06289972 Recruiting - Cystic Fibrosis Clinical Trials

Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire

Start date: February 20, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.