The research company AstraZeneca is conducting 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.
It is planned to include 542 participants. Actual study start date is September 27, 2022. The researchers expect to complete the study by June 21, 2024.
Among patients who can be enrolled are participants from 40 to 80 years of age inclusive, who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines; who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening.
The study will be conducted in several investigational sites in the following countries: the USA, Argentina, Bulgaria, Canada, Germany, Mexico, Poland, Turkey, the United Kingdom.
For more complete list of the inclusion and exclusion criteria, and for the sites contact details, please visit: https://ichgcp.net/clinical-trials-registry/NCT05573464.