A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
• Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
• A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 0.7.
• At Visit 1: A pre-bronchodilator FEV1 \< 80%.
• At Visit 1: Peripheral blood eosinophil count \< 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count \> 300 cells/mm³ in the past 12 months.
• At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
• At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of \> 135% of predicted normal FRC.
• At Visit 2: A post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted normal value.
• Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
• Female participants must either be not of childbearing potential or using a form of highly effective birth control.
• All women of child bearing potential must have a negative pregnancy test at the Visit 1.