Study identifier:D5985C00008
ClinicalTrials.gov identifier:NCT06297668
EudraCT identifier:N/A
CTIS identifier:2023-504089-43-00
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
Chronic Obstructive Pulmonary Disease
Phase 1
Yes
Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
All
42
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
PAREXEL
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.
Location
Location
Berlin, Germany, 14050
Arms | Assigned Interventions |
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Active Comparator: BGF MDI HFA Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroalkane with AeroChamber Plus Flow-Vu spacer-reference formulation | Drug: Treatment A: BGF MDI HFA Participants will receive 4 inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer. Device: AeroChamber Plus Flow-Vu spacer Participants will receive 4 inhalations of BGF MDI HFA (Treatment A) and BGF MDI HFO (Treatment B) as a single dose with spacer. |
Active Comparator: BGF MDI HFO with spacer Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin with AeroChamber Plus Flow-Vu spacer-test formulation | Drug: Treatment B: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer. Device: AeroChamber Plus Flow-Vu spacer Participants will receive 4 inhalations of BGF MDI HFA (Treatment A) and BGF MDI HFO (Treatment B) as a single dose with spacer. |
Active Comparator: BGF MDI HFO without spacer Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin without AeroChamber Plus Flow-Vu spacer | Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without spacer. |
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