Study identifier:D5982C00007
ClinicalTrials.gov identifier:NCT04609878
EudraCT identifier:2020-001520-34
CTIS identifier:2023-505787-11-00
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants with Inadequately Controlled Asthma
asthma
Phase 3
No
BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg
All
2212
Interventional
12 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) | Drug: BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler Other Name: BGF |
Experimental: BGF MDI 320/14.4/9.6 μg BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) | Drug: BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler Other Name: BGF |
Active Comparator: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) | Drug: BFF MDI 320/9.6 μg Budesonide and formoterol fumarate metered dose inhaler Other Name: BFF |
Active Comparator: Symbicort® Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg | Drug: BFF pMDI 320/9 μg Budesonide/formoterol fumarate pressurized metered dose inhaler Other Name: Symbicort® |