Witney

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.

Researchers are conducting a prospective observational study to evaluate the health of multiple organs using multiparametric abdominal magnetic resonance imaging (MRI) in adults with type 2 diabetes who have no history of cardiovascular disease. The study aims to determine if MRI metrics can predict future clinical events over five years, focusing on cardiovascular outcomes such as heart attacks, strokes, and hospitalizations. Participants will not receive any new treatments as part of this study; instead, they will undergo standard care and two study visits. The first visit involves physical measurements and collection of blood and urine samples to assess diabetes status and biomarkers. The second visit includes a multi-organ MRI scan. Both visits occur within 28 days of the initial screening, which includes medical review and informed consent. During the five-year participation, researchers will collect MRI data, clinical outcomes, blood and urine samples, and access medical records from NHS England and local healthcare providers. Follow-up data on hospital admissions and mortality will be gathered at 1, 3, and 5 years after the baseline assessment. The primary outcome is the incidence of major cardiovascular events over three years based on baseline MRI findings.