Study identifier:D5988C00001
ClinicalTrials.gov identifier:NCT06067828
EudraCT identifier:N/A
CTIS identifier:2022-502274-16-00
A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants with COPD (ATHLOS)
Chronic Obstructive Pulmonary Disease
Phase 3
No
Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate, Treatment B: Budesonide and Formoterol Fumarate, Treatment C : Placebo
All
180
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 |
---|---|
Active Comparator: BGF MDI Pressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation. | Drug: Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID). |
Active Comparator: BFF MDI Pressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation. | Drug: Treatment B: Budesonide and Formoterol Fumarate Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID. |
Placebo Comparator: Placebo Placebo as pressurized inhalation suspension. | Drug: Treatment C : Placebo Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID. |