Study identifier:D5980C00019
ClinicalTrials.gov identifier:NCT03836677
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-blind, Two Treatment, Two Period, Chronic dosing (4 weeks), Crossover, Multi-center Pilot study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image based Airway Volumes and Resistance in Subjects with Moderate to Severe COPD
Chronic obstructive pulmonary disease (COPD)
Phase 3
No
-
All
23
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2021 by AstraZeneca
AstraZeneca
-
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds. This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).
Location
Location
GRONINGEN, Netherlands, 9713 GZ
Location
Zutphen, Netherlands, 7207 AE
Location
EINDHOVEN, Netherlands, 5623 EJ
Location
Erpent, Belgium, 5101
Arms | Assigned Interventions |
---|---|
Experimental: BGF-GFF Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate | Combination Product: BGF Treatment with Budesonide/Glycopyrronium/FormoterolFumarate Combination Product: GFF Treatment with Glycopyrronium/Formoterol Fumarate |
Experimental: GFF-BGF Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate | Combination Product: BGF Treatment with Budesonide/Glycopyrronium/FormoterolFumarate Combination Product: GFF Treatment with Glycopyrronium/Formoterol Fumarate |
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