A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
105actual
Sites
1
Country
United States
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 | 2025-01-23 | actual | When the study began enrolling |
| Primary completion | 2025-06-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-01 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: Treatment A: BGF MDI HFO — also filed as Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFO
- Drug: Treatment B: BGF MDI HFA — also filed as Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFA
Primary outcomes
what the primary-completion date above is the date OFArea under concentration curve from time 0 to the last quantifiable concentration (AUClast)
measured Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Maximum observed drug concentration (Cmax)
measured Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
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