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
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Chronic Obstructive Pulmonary Disease, Hyperinflation
In brief
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.
Key facts
- Study ID
- NCT07073950
- Run by
- AstraZeneca
- People needed
- 56
- Starts
- 2025-11-24
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-07-24
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
- History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
- History of myocardial infarction or acute coronary syndrome.
- History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
- Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
- Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
- Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
- Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.
Where it is running
- Research Site — Hanover, Germany (enrolling)
- Research Site — Berlin, Germany (enrolling)
- Research Site — Frankfurt, Germany (enrolling)
- Research Site — Ahrensburg, Germany (enrolling)
- Research Site — Manchester, United Kingdom (enrolling)
- Research Site — London, United Kingdom (enrolling)
- Research Site — Harefield, United Kingdom
Full record on ClinicalTrials.gov
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