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A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation
Sponsor: AstraZeneca
Summary
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Official title: A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-11-24
Completion Date
2027-05-31
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Budesonide/Glycopyrronium/Formoterol Fumarate
BGF will be administered as 2 inhalations via oral route of administration
Placebo
Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Locations (6)
Research Site
Ahrensburg, Germany
Research Site
Berlin, Germany
Research Site
Hanover, Germany
Research Site
Harefield, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom