A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Parexel.
Phase
Phase 1
Status
Withdrawn
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
0actual
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
Why the sponsor stopped it
Study no longer required.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-17 | estimated | When the study began enrolling |
| Primary completion | 2025-02-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-27 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy
Interventions
- Drug: Treatment A: BGF MDI HFA
- Drug: Treatment B: BGF MDI HFO
- Drug: Treatment C: BGF MDI HFO
- Device: AeroChamber Plus Flow-Vu Spacer
Primary outcomes
what the primary-completion date above is the date OFArea Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI
measured Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Concentration (Cmax) of BGF MDI
measured Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
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