Study identifier:D5985C00002
ClinicalTrials.gov identifier:NCT06075095
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomised, Placebo-Controlled, Double-Blind, Multi-Centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared with BGF Delivered by MDI HFA in Participants with Chronic Obstructive Pulmonary Disease
COPD (Chronic Obstructive Pulmonary Disease)
Phase 3
No
BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg, Placebo MDI HFA
All
255
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Sequence 1 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 1: BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |
Experimental: Treatment Sequence 2 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 2: BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |
Experimental: Treatment Sequence 3 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 3: BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |
Experimental: Treatment Sequence 4 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 4: BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |
Experimental: Treatment Sequence 5 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 5: Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |
Experimental: Treatment Sequence 6 Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions in the following sequence. Sequence 6: Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg | Drug: BGF MDI HFO 320/14.4/9.6μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFO (HFO-1234ze) Drug: BGF MDI HFA 320/14.4/9.6 μg Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): Other Name: Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Other Name: Delivered by MDI HFA Drug: Placebo MDI HFA Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) Other Name: Placebo |