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HomeHeart & CirculationA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol…

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

25 March 2026 Read original ↗
🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE4
Participants
ALL
Age Range
40 Years – 80 Years

About This Trial

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.

Who Can Join?

Key Inclusion Criteria: * Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking. * A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7. * At Visit 1: A pre-bronchodilator FEV1 < 80%. * At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months. * At Visit 1: Modified Medical Research Council (mMRC) ≥ 1. * At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC. * At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value. * Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment. * Female participants must either be not of childbearing potential or using a form of highly effective birth…

⚠ Always speak to your doctor before applying to any clinical trial.

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