Study identifier:D5985C00009
ClinicalTrials.gov identifier:NCT06340581
EudraCT identifier:N/A
CTIS identifier:2023-509914-12-00
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
Healthy
Phase 1
Yes
Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
All
0
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
PAREXEL
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 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |
Experimental: Treatment Sequence 2: ACB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |
Experimental: Treatment Sequence 3: BAC Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |
Experimental: Treatment Sequence 4: BCA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |
Experimental: Treatment Sequence 5: CAB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |
Experimental: Treatment Sequence 6: CBA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 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) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. | Drug: Treatment A: BGF MDI HFA Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment B: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. Drug: Treatment C: BGF MDI HFO Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. 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 AeroChamber Plus Flow-Vu spacer. |