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.
A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
History of myocardial infarction or acute coronary syndrome.
History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
Crossover
Budesonide/Glycopyrronium/Formoterol Fumarate
DrugBGF will be administered as 2 inhalations via oral route of administration
Placebo
DrugMatching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler
DeviceParticipants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography
The effect of BGF relative to placebo on FRC/TLC will be evaluated.
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography
The effect of BGF relative to placebo on RV/TLC will be evaluated.
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AstraZeneca
Lead sponsor
Parexel
Collaborator
