A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
297actual
Sites
87
Countries
Argentina, Bulgaria, Canada +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-11 | actual | When the study began enrolling |
| Primary completion | 2025-08-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-12 | actual | The whole study's end, after follow-up |
| First posted | 2023-10-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- COPD (Chronic Obstructive Pulmonary Disease)
Interventions
- Drug: BGF MDI HFO 320/14.4/9.6μg — also filed as Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF), Delivered by MDI HFO (HFO-1234ze)
- Drug: BGF MDI HFA 320/14.4/9.6 μg — also filed as Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF), Delivered by MDI HFA
- Drug: Placebo MDI HFA — also filed as Placebo
Primary outcomes
what the primary-completion date above is the date OFChanges in FEV1 AUC (0-4)
measured Change from baseline at Day 29
Change in morning pre-dose trough FEV1
measured Change from baseline at Day 29
Changes in FEV1 AUC (0-4)
measured Change from baseline at Day 29
Change in morning pre-dose trough FEV1
measured Change from baseline at Day 29
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