This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%
Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
End-stage renal disease requiring renal replacement therapy
History of heart or lung transplant or actively listed for heart or lung transplant.
Implanted left ventricular assist device or implant anticipated in < 3 months.