Study of Once-Daily Single Inhaler Triple Therapy FFUMECVI Effects Using 129-Xe MRI in Adults 50-85 With Moderate to Severe COPD and Different Risks of Flare-Ups

What this Trial Is About

Researchers are evaluating how a 12-week daily inhaler therapy combining fluticasone furoate, umeclidinium, and vilanterol affects adults aged 50 to 85 with moderate to severe COPD. The study includes equal numbers of males and females with persistent symptoms and compares those at low and high risk of COPD flare-ups. It aims to understand if this triple therapy improves lung ventilation as measured by 129-Xenon MRI and how this relates to lung function tests. Participants will use a single Ellipta inhaler containing the three medications once daily for 12 weeks, with an optional additional 48 weeks of treatment. They will attend two main visits at baseline and after 12 weeks, with an optional third visit at 48 weeks to assess longer-term effects. The study observes participants responses during and after therapy. During visits, participants undergo various lung function tests including spirometry, plethysmography, oscillometry, and exhaled nitric oxide measurement. They will have 129-Xe MRI scans and chest CT scans before and after bronchodilator use. Questionnaires assessing respiratory symptoms, health status, and exertion are completed, along with a blood draw for inflammatory markers. Researchers measure ventilation defect percentage and lung function changes to evaluate therapy effects over time.

129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation