A study to assess the pharmacokinetics and safety 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:D5985C00008

ClinicalTrials.gov identifier:NCT06297668

EudraCT identifier:N/A

CTIS identifier:2023-504089-43-00

Study Complete

Official Title

A Phase I, Randomized, Partial Double-blind, Single-dose, 3-Way Cross-over Study to Assess the Total Systemic Exposure 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 Total Systemic Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer

Medical condition

Chronic Obstructive Pulmonary Disease

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

42

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 29 Apr 2024
Primary Completion Date: 11 Jun 2024
Study Completion Date: 11 Jun 2024

Study design

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

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria