A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) metered dose inhaler (MDI) Hydrofluoroolefin (HFO) with a spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) with a spacer (Treatment A), as well as BGF MDI HFO without a spacer (Treatment C)

Study identifier:D5985C00009

ClinicalTrials.gov identifier:NCT06340581

EudraCT identifier:N/A

CTIS identifier:2023-509914-12-00

Terminated/Withdrawn

Official Title

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO

Sex

All

Actual Enrollment

0

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 17 Oct 2024
Estimated Primary Completion Date: 27 Feb 2025
Estimated Study Completion Date: 27 Feb 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria