This is a Phase 3 randomized, double-blind, 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO 320/14.4/9.6 μg twice daily (BID) with BGF MDI HFA 320/14.4/9.6 μg BID in participants with moderate to very severe COPD. For the 12-week study, 542 participants will be randomized to treatments BGF MDI HFO and BGF MDI HFA in a 1:1 ratio. Randomization will be stratified by region (Americas, Europe) and COPD disease severity (percent predicted FEV1 ≥ 50%, percent predicted FEV1 < 50%). Subsequently, the 120 participants per treatment arm who were randomized to the extended study will continue and remain on the randomized treatment to 52 weeks.
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.