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)

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Hyperinflation
• Interventions: Drug: Budesonide/Glycopyrronium/Formoterol Fumarate; Drug: Placebo; Device: Metered dose inhaler

• Registration Number: NCT07073950
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and pulmonary function will be evaluated in patients with COPD and hyperinflation.

The study will comprise of:

* Screening period

* Participants will receive placebo inhaler and salbutamol before randomization

* Two treatment periods where participants will be randomized 1:1 to receive either the study intervention BGF MDI followed by matching placebo or study interventions in reverse order

* A final follow-up period

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-30
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1: BGF MDI and Placebo	Budesonide/Glycopyrronium/Formoterol Fumarate	Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
Sequence 1: BGF MDI and Placebo	Placebo	Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
Sequence 1: BGF MDI and Placebo	Metered dose inhaler	Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
Sequence 2: Placebo and BGF MDI	Budesonide/Glycopyrronium/Formoterol Fumarate	Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
Sequence 2: Placebo and BGF MDI	Placebo	Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
Sequence 2: Placebo and BGF MDI	Metered dose inhaler	Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.

Primary Outcome Measures

Name	Time	Method
Change from baseline in left ventricular end diastolic volume (LVEDV) measured by magnetic resonance imaging (MRI)	Up to 3 weeks	The effect of BGF relative to placebo on LVEDV in participants with COPD and hyperinflation will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography	Up to 3 weeks	The effect of BGF relative to placebo on FRC/TLC will be evaluated.
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography	Up to 3 weeks	The effect of BGF relative to placebo on RV/TLC will be evaluated.