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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
This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.
This is a Phase I, randomized, partial double-blind, single dose, three way cross-over study to assess the effect of total systemic exposure of BGF when administered as 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 in healthy participants (male or female). The study will comprise of: * A Screening Period of up to 27 days prior to first dosing. * Three treatment periods: participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment, with a washout period of 3 to 7 days between each dose administration. * Follow-up: a final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3. Participants will receive all 3 treatments as a single dose (4 inhalations) (Treatment A \[BGF MDI HFA with AeroChamber Plus Flow-Vu spacer - reference formulation\], Treatment B \[BGF MDI HFO with AeroChamber Plus Flow-Vu spacer - test formulation\], and Treatment C \[BGF MDI HFO without spacer\]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Berlin, Germany
Start Date
April 29, 2024
Primary Completion Date
June 11, 2024
Completion Date
June 11, 2024
Last Updated
August 13, 2025
42
ACTUAL participants
Treatment A: BGF MDI HFA
DRUG
Treatment B: BGF MDI HFO
DRUG
Treatment C: BGF MDI HFO
DRUG
AeroChamber Plus Flow-Vu spacer
DEVICE
Lead Sponsor
AstraZeneca
Collaborators
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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