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.
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and lung function will be evaluated in patients with COPD and hyperinflation. The study will comprise of: * Screening period * Participants will receive placebo inhaler and salbutamol before randomization * Two treatment periods of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2 * A final follow-up period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
BGF will be administered as 2 inhalations via oral route of administration
Matching placebo will be administered as 2 inhalations via oral route of administration
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Research Site
Ahrensburg, Germany
NOT_YET_RECRUITINGResearch Site
Berlin, Germany
RECRUITINGResearch Site
Frankfurt, Germany
NOT_YET_RECRUITINGResearch Site
Hanover, Germany
RECRUITINGResearch Site
Harefield, United Kingdom
NOT_YET_RECRUITINGResearch Site
London, United Kingdom
RECRUITINGResearch Site
Manchester, United Kingdom
NOT_YET_RECRUITINGChange from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
Time frame: Up to 3 weeks
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography
The effect of BGF relative to placebo on FRC/TLC will be evaluated.
Time frame: Up to 3 weeks
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography
The effect of BGF relative to placebo on RV/TLC will be evaluated.
Time frame: Up to 3 weeks
AstraZeneca Clinical Study Information Center
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