Roscoff

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Cystic fibrosis is a genetic disease caused by mutations in the gene responsible for the CFTR protein, leading to respiratory and digestive problems that affect patient outcomes. Digestive damage often results in malnutrition from several causes, including low energy intake and higher energy needs. Research shows a link between lower lean body mass and poorer lung function. In 2019, health authorities redefined undernutrition to include reduced muscle mass or function as a key diagnostic sign. The new therapy Elexacaftor-Tezacaftor-Ivacaftor, approved in 2021, aims to improve CFTR protein function, showing early benefits in lung function and weight gain but also raising concerns about overweight and metabolic issues. New dietary and physical activity strategies are therefore important for managing these changes. This study evaluates a coordinated diet and adapted physical activity program called DIAPASOM, delivered remotely by a specialist instructor along with personalized dietetic care by a dietician over one year. The program is designed to improve muscle mass and function in adult cystic fibrosis patients who have been treated with Elexacaftor-Tezacaftor-Ivacaftor for at least six months. The goal is to see if this combined approach can increase the percentage of lean body mass after 12 months. Participants will be monitored for changes in lean body mass as a percentage of total body mass from the time of randomization up to 12 months. The study involves regular assessments of muscle mass, physical capabilities, and nutritional status. Researchers will track adherence to the diet and physical activity program and evaluate safety and overall health during the year-long period. This trial aims to improve muscle strength and metabolic health through structured support tailored to individuals living with cystic fibrosis.

Pulmonary Embolism (PE) is a serious and common condition with a high mortality rate within three months after diagnosis. Treatment involves anticoagulation for at least three months, but many patients continue to experience breathlessness and reduced quality of life after treatment. These symptoms may result from factors like residual artery obstruction, reduced exercise capacity, depression, or cardio-respiratory problems. Pulmonary rehabilitation (PR), known to help in other respiratory diseases and after heart attacks, is being studied to see if it can improve quality of life and breathlessness in patients at least three months after PE who still have these difficulties. The study compares 20 sessions of pulmonary rehabilitation delivered over three months at a respiratory rehabilitation center. It enrolls 112 patients who have completed between three and eight months of anticoagulation treatment for symptomatic PE and who report impaired quality of life or ongoing breathlessness. This trial is the first large randomized assessment of PR started at least three months after acute PE, aiming to isolate the effects of rehabilitation from those of anticoagulation. Participants will be followed to evaluate their quality of life using the PEmbQoL score measured three months after starting PR. Researchers will assess symptoms, daily life impact, and safety during and after the rehabilitation program. The study focuses on the potential benefits of delayed PR for improving life quality and reducing breathlessness in patients who have completed the initial anticoagulant treatment phase following PE.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Researchers are studying children from birth to 18 years old with cystic fibrosis to see if the presence of Porphyromonas bacteria can predict the risk of early colonization by Pseudomonas aeruginosa. This study is focused on understanding how these bacteria might serve as biomarkers to help predict clinical outcomes in this population. The study is conducted at a single center and includes three phases: pre-inclusion at the first visit to the cystic fibrosis care center after a positive screening confirmed by sweat test and genetic testing; inclusion which can occur between the second visit (around 2 months old) and six months of age; and follow-up until the child reaches 36 months old. Participants will provide samples including bronchial secretions, blood, stools, skin samples, dental plaque, and urine as part of their usual clinical care. During follow-up, children will have regular clinical visits, respiratory tests, and biological sample collections at the care center. Dermatological and dental check-ups will be scheduled annually at a hospital in Brest. Researchers will monitor the presence of Pseudomonas aeruginosa in sputum samples over three years to assess the predictive value of Porphyromonas as a biomarker. The study also includes collection of various clinical and paraclinical data as part of routine care.

Researchers are investigating the use of Virtual Reality (VR) and Active Video Games (AVG) in pediatric rehabilitation to help children with chronic conditions who need long-term care. These technologies have shown promise in improving motor and cognitive functions, managing pain, and addressing attention disorders. Despite positive research results, VR and AVG are not widely used in clinical practice at the Ty Yann and Perharidy pediatric rehabilitation services, where professionals have expressed interest in better integrating these tools. The study involves collaboration with rehabilitation professionals, health managers, and children to identify barriers and facilitators affecting the use of VR in these centers. The project has three phases: first, focus groups and interviews will explore current challenges and supports for VR use; second, specific strategies will be implemented to improve VR integration; and third, the effectiveness of these strategies will be assessed by tracking VR usage frequency and gathering feedback from participants. Participants will engage in focus groups and interviews throughout the study, which runs from October 2024 to November 2025. Researchers will collect data on VR usage, ease of use, and participant perspectives. The goal is to better understand how to implement VR in everyday pediatric rehabilitation, improving motivation and treatment intensity for children. Outcomes include the number of VR sessions per week and qualitative insights based on the Consolidated Framework for Implementation Research (CFIR).