Roscoff

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Cystic fibrosis is a genetic disease caused by mutations in the gene for the CFTR protein, leading to respiratory and digestive problems that affect health outcomes. Digestive issues can cause malnutrition with reduced muscle mass, which is linked to poorer lung function. Recently, undernutrition has been redefined to include loss of muscle mass or function. The therapy Elexacaftor-Tezacaftor-Ivacaftor, approved in 2021, aims to improve CFTR protein function and has shown early benefits in lung function and weight gain, but also new nutritional challenges like overweight and metabolic problems. This study explores how diet and exercise can help these patients. The study compares two groups of adults with cystic fibrosis treated with Elexacaftor-Tezacaftor-Ivacaftor. One group participates in the DIAPASOM program, which includes a year-long remote adapted physical activity program led by a specialist instructor, with phases of supervised and independent sessions, combined with personalized dietetic care involving consultations every three months and phone follow-ups. The other group receives usual care for nutrition and physical activity. Participants will be followed for 12 months to assess changes in lean body mass as a percentage of total body mass. Researchers will also measure fat mass, weight, BMI, muscle strength and endurance, flexibility, lung function, physical activity levels, sedentary time, and quality of life. The programs feedback questionnaire will be collected at 12 months. This thorough evaluation aims to understand how coordinated diet and adapted physical activity affect muscle mass and overall health in cystic fibrosis patients.

Researchers are investigating the effects of the new combination treatment elexacaftortezacaftorivacaftor in children with cystic fibrosis, a disease that primarily affects the lungs and digestive system through chronic inflammation. This trial aims to understand how this treatment influences the lung and gut microbiota and inflammation. The study builds on previous research with a different treatment combination and uses an existing cohort and sample collection system to gather biological data over one year. Participants will receive elexacaftortezacaftorivacaftor as part of their routine care. Samples of sputum, stool, and blood will be collected at treatment start, six months, and one year later to analyze changes in lung and digestive bacterial and fungal communities. This approach allows researchers to study the interplay between the lung and gut microbiota during treatment. During the study, participants will provide biological samples at three time points for detailed microbiota and inflammation analysis. Researchers will measure the composition of digestive and pulmonary bacterial and fungal microbiota at baseline and after one year of treatment. The study lasts one year from treatment initiation, with ongoing monitoring to assess the treatments impact on these important health markers.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Researchers are investigating the use of Porphyromonas as a biomarker to predict the risk of initial colonization by Pseudomonas aeruginosa in children aged 0 to 18 years who have cystic fibrosis. This study is descriptive and monocentric, aiming to identify and validate biomarkers that may predict clinical evolution in these patients. The study consists of three phases pre-inclusion at the first visit to the Cystic Fibrosis Reference Center CRCM, inclusion between the second visit around 2 months old and six months of age, and follow-up until the child reaches 36 months old. During the study, clinical and paraclinical data along with biological samples such as bronchial secretions, blood, stools, superficial skin, dental plaque, and urine will be collected. Dermatological and dental follow-ups are scheduled annually at a regional hospital. Participants will attend visits based on the usual care schedule for cystic fibrosis infants. Respiratory tests and sample collections will be performed during these visits at the CRCM. The primary outcome measured is the presence of Pseudomonas aeruginosa in bronchial secretions over the three-year period. The study includes monitoring through clinical exams and biological testing to track the development and colonization status of the children.

Cystic fibrosis CF causes changes in how the body processes antibiotics, affecting absorption, distribution, metabolism, and elimination. These changes historically led to higher antibiotic doses to reach effective concentrations and improve lung health. The introduction of the triple combination drug elexacaftortezacaftorivacaftor ETI has greatly improved lung function, nutrition, inflammation, and quality of life in CF patients, while also altering respiratory infections and reducing lung flare-ups. This observational study tracks intravenous antibiotic levels in adolescents and adults with CF who are receiving ETI during lung exacerbations needing antibiotic treatment. Routine antibiotic therapy and drug monitoring follow standard care practices, with no additional interventions assigned. The study compares antibiotic concentrations to current recommended targets to understand how ETI may affect antibiotic dosing needs. Participants will be monitored through blood tests to measure antibiotic levels on day 3 of therapy, along with clinical assessments of weight, temperature, appetite, fatigue, breathing difficulty, sputum amount and quality, kidney function, and inflammation at various points during treatment. Treatment adherence and any side effects will also be tracked over about 14 days. The study aims to help optimize antibiotic dosing in CF patients treated with ETI while minimizing side effects.

Researchers are studying how to better use Virtual Reality VR and Active Video Games AVG in pediatric rehabilitation for children with chronic conditions who need long-term care. Although VR and AVG show promise in improving motor skills, cognitive function, pain management, and attention disorders, they are not commonly used in clinical practice at the Ty Yann and Perharidy centers of the ILDYS Foundation. This project aims to identify barriers and facilitators to VR use and develop strategies to integrate these tools more effectively in rehabilitation care for children. The study involves three stages first, focus groups and interviews will be conducted with rehabilitation professionals, healthcare managers, and children receiving rehabilitation to understand current challenges and opportunities with VR. Second, specific strategies based on this feedback will be implemented to improve VR use. Third, the impact of these strategies will be evaluated by tracking the number of VR sessions per week and gathering opinions through further focus groups and interviews. Participants will include rehabilitation professionals, decision makers, and children aged 6 to 18 who have experience using VR during rehabilitation. The study will collect socio-demographic data and feedback about VR use and ease of use. Outcomes include the frequency of VR use and qualitative feedback from participants based on a recognized implementation research framework. The study will run from October 2024 to November 2025, with continuous monitoring and evaluation throughout this period.