A study to evaluate the effects of BGF and GFF on Specific Image based Airway Volumes and Resistance in Subjects with Moderate to Severe COPD
Study identifier:D5980C00019
ClinicalTrials.gov identifier:NCT03836677
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
BGF, GFF
Sex
All
Actual Enrollment
23
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 26 Feb 2019
Primary Completion Date: 11 Nov 2019
Study Completion Date: 11 Nov 2019
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
