RecruitingPhase 4NCT07073950

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

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


Sponsor

AstraZeneca

Enrollment

56 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a triple-combination inhaler (budesonide, glycopyrronium, and formoterol) helps improve heart and lung function in people with COPD who also have lung overinflation — where air gets trapped in the lungs. **You may be eligible if...** - You are a current or former smoker with at least 10 pack-years of smoking history - You have a confirmed COPD diagnosis based on breathing tests - Your lung function falls within a moderate-to-severe range (FEV1 between 30–80% of predicted normal) - You have significant air trapping in your lungs (hyperinflation confirmed by breathing tests) - You experience breathlessness (mMRC score of 1 or higher) - Your blood eosinophil count is below 300 cells/mm³ - You are already on at least one inhaled COPD maintenance medication **You may NOT be eligible if...** - You have high eosinophil counts in your blood (over 300 cells/mm³) in the past 12 months - Your lung function is too severely impaired (FEV1 below 30%) or too mildly impaired - You do not have lung overinflation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBudesonide/Glycopyrronium/Formoterol Fumarate

BGF will be administered as 2 inhalations via oral route of administration

DRUGPlacebo

Matching placebo will be administered as 2 inhalations via oral route of administration

DEVICEMetered dose inhaler

Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.


Locations(7)

Research Site

Ahrensburg, Germany

Research Site

Berlin, Germany

Research Site

Frankfurt, Germany

Research Site

Hanover, Germany

Research Site

Harefield, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07073950


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