Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-11
56
Participants Needed
7
Research Sites
79 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current or former smoker with a history of 60 10 pack-years of tobacco smoking
- Diagnosis of COPD confirmed by post-bronchodilator FEV1/FVC < 0.7
- Pre-bronchodilator FEV1 < 80% at Visit 1
- Peripheral blood eosinophil count < 300 cells/mm�b3 at Visit 1 with no history above 300 cells/mm�b3 in past 12 months
- Modified Medical Research Council (mMRC) score 60 1 at Visit 1
- Pre-bronchodilator functional residual capacity (FRC) > 135% of predicted normal at Visit 2
- Post-bronchodilator FEV1 60 30% and < 80% of predicted normal at Visit 2
- On mono-, dual-, or triple-inhaled maintenance COPD treatment
- Female participants not of childbearing potential or using highly effective birth control
- Negative pregnancy test for women of childbearing potential at Visit 1
You will not qualify if you...
- Diagnosis of asthma, asthma-COPD overlap, or other chronic respiratory diseases except COPD
- History of COPD exacerbation requiring hospitalisation or 2+ exacerbations needing systemic corticosteroids
- History of myocardial infarction or acute coronary syndrome
- Clinically significant atrial or ventricular arrhythmia confirmed by ECG
- Presence of cardiac implantable electronic device
- ECG QTcF interval > 460 ms for males or > 480 ms for females at Visit 1
- Respiratory tract infection within 8 weeks prior to Visit 1 or during screening
- History of lung lobectomy, lung volume reduction within 3 months of Visit 1, or lung transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Research Site
Ahrensburg, Germany, 22926
Not Yet Recruiting
2
Research Site
Berlin, Germany, 14050
Actively Recruiting
3
Research Site
Frankfurt, Germany, 60596
Not Yet Recruiting
4
Research Site
Hanover, Germany, 30625
Actively Recruiting
5
Research Site
Harefield, United Kingdom, UB9 6JH
Withdrawn
6
Research Site
London, United Kingdom, W1T 6AH
Actively Recruiting
7
Research Site
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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