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A Phase I, Randomized, Partial Double-blind, Single dose, 3-Way Cross-over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509914-12-00
Acronym
D5985C00009
Enrollment
132
Registered
2024-04-22
Start date
2024-04-29
Completion date
2024-08-02
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers, Not applicable

Interventions

None listed

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026