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
Budesonide/Glycopyrronium/Formoterol Fumarate: BGF will be administered as 2 inhalations via oral route of administration
Placebo: Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhaler: Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Study 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
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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 control.
* All women of child bearing potential must have a negative pregnancy test at the Visit 1.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI) — Up to 3 weeks The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.