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

NCT07073950 | Recruiting Phase 4 FDA Drug FDA Device

• 2 other identifiers: D5980C000482025-521987-37-00
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 7

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.

Conditions

Chronic Obstructive Pulmonary Disease; Hyperinflation

Keywords

Metered Dose Inhalers (MDI); Inhaled Corticosteroid (ICS); Long-acting muscarinic antagonist (LAMA); Long-acting beta2 agonist (LABA)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)

  The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.

  Up to 3 weeks

Secondary Outcomes (2)

• Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography

  Up to 3 weeks

• Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography

  Up to 3 weeks

Study Arms (2)

Sequence 1: BGF MDI and Placebo

EXPERIMENTAL

Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.

Drug: Budesonide/Glycopyrronium/Formoterol Fumarate; Drug: Placebo; Device: Metered dose inhaler

Sequence 2: Placebo and BGF MDI

EXPERIMENTAL

Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.

Drug: Budesonide/Glycopyrronium/Formoterol Fumarate; Drug: Placebo; Device: Metered dose inhaler

Interventions

Budesonide/Glycopyrronium/Formoterol Fumarate DRUG

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

Sequence 1: BGF MDI and Placebo; Sequence 2: Placebo and BGF MDI

Placebo DRUG

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

Sequence 1: BGF MDI and Placebo; Sequence 2: Placebo and BGF MDI

Metered dose inhaler DEVICE

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

Sequence 1: BGF MDI and Placebo; Sequence 2: Placebo and BGF MDI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (7)

Research Site

Ahrensburg, 22926, Germany

NOT YET RECRUITING

Research Site

Berlin, 14050, Germany

RECRUITING

Research Site

Frankfurt, 60596, Germany

NOT YET RECRUITING

Research Site

Hanover, 30625, Germany

RECRUITING

Research Site

Harefield, UB9 6JH, United Kingdom

NOT YET RECRUITING

Research Site

London, W1T 6AH, United Kingdom

RECRUITING

Research Site

Manchester, M23 9QZ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebulizers and Vaporizers; Equipment and Supplies

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 20, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secureresearchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DE (4); GB (3)