Effect of BudesonideGlycopyrroniumFormoterol Inhaler Compared to Placebo on Heart and Lung Function in Adults with COPD and Lung Hyperinflation

What this Trial Is About

Researchers are investigating the effects of BudesonideGlycopyrroniumFormoterol Fumarate metered dose inhaler BGF MDI compared with a placebo inhaler on heart and lung function in adults aged 40 to 80 years who have chronic obstructive pulmonary disease COPD and lung hyperinflation. This Phase IV, randomized, double-blind study involves multiple centers and aims to understand how BGF MDI affects cardiac and lung function in this population. Participants will undergo a screening period, followed by receiving placebo inhaler and salbutamol before randomization. The study includes two treatment periods, each lasting 21 days, where participants are randomly assigned to receive either BGF MDI or placebo inhaler first, then switch to the other treatment in the second period. Treatments are given as two inhalations via oral route using a metered dose inhaler. After these periods, a final follow-up phase completes the study. During the trial, participants will be assessed with magnetic resonance imaging MRI to measure changes in left ventricular end diastolic volume indexed by body surface area, along with lung function tests using body plethysmography to evaluate lung volumes. The study monitors participants closely through the treatment and follow-up periods, evaluating changes in heart and lung function to understand the impact of BGF MDI compared to placebo. The total participation includes screening, two 21-day treatment periods, and final follow-up assessments.

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation