At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 559 enrolled
Drug / intervention
BGF MDI HFO 320/14.4/9.6 μg +1 moredrug
Likely dose
BGF MDI HFO 320/14.4/9.6 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, 12-Week (With an Extension to 52 Weeks in a Subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF Delivered by MDI HFA in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating BGF MDI HFO 320/14.4/9.6 μg and BGF MDI HFA 320/14.4/9.6 μg for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 559 participants across 91 sites in 9 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Bulgaria, Canada, Germany, Mexico, Poland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartSep 2022
First PostedOct 2022
Primary CompletionMar 2024
TodayJul 2026
First PostedOct 10, 2022
Enrollment StartSep 27, 2022
Primary CompletionMar 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.7 years ago
Interventions
BGF MDI HFO 320/14.4/9.6 μgdrug
Budesonide, Glycopyrronium, and Formoterol Fumarate
BGF MDI HFA 320/14.4/9.6 μgdrug
Budesonide, Glycopyrronium, and Formoterol Fumarate