Study identifier:D5985C00008
ClinicalTrials.gov identifier:N/A
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 Feb 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
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Experimental: Treatment Sequence 1: ABC Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFO without spacer (Treatment C) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |
Experimental: Treatment Sequence 2: ACB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFO with spacer (Treatment B) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |
Experimental: Treatment Sequence 3: BAC Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFO with spacer (Treatment B), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO without spacer (Treatment C) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |
Experimental: Treatment Sequence 4: BCA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFO with spacer (Treatment B) followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFA with spacer (Treatment A) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |
Experimental: Treatment Sequence 5: CAB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO with spacer (Treatment B) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |
Experimental: Treatment Sequence 6: CBA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFA with spacer (Treatment A) with single dose (4 puffs) on Day 1 of all treatment periods. | 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. 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. Drug: Treatment C: BGF MDI HFO Participants will receive 4 inhalations of BGF MDI HFO as a single dose without 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. |