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) - ORATOS

Inclusion Criteria

• -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.
• Exclusion Criteria:
• -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 atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
• -Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
• -Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
• -Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
• -Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.