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Looking for participantsPhase4

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

Sponsor: AstraZeneca

NCT ID: NCT07073950

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Budesonide/Glycopyrronium/Formoterol Fumarate (drug), Placebo (drug), Metered dose inhaler (device)
How long the study runs
Study runs about 18 months (dates as stated)
About the drug or intervention
Budesonide/Glycopyrronium/Formoterol Fumarate — drug: BGF will be administered as 2 inhalations via oral route of administration · Placebo — drug: Matching placebo will be administered as 2 inhalations via oral route of administration · Metered dose inhaler — device: Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
56
Started
2025-11-24
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease
  • • Phase4 - 56 participants
  • • 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

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with chronic obstructive pulmonary disease

Where?

  • • Harefield - Research Site
  • • London - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 lung 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 of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2 * A final follow-up period

Chronic Obstructive Pulmonary DiseaseHyperinflation

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ a negative pregnancy test at the Visit 1

What the study is looking for

  • ✓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...
  • ✓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...
  • ✓At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.

Who cannot take part

  • ✗History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic...
  • ✗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 heart implantable electronic device, including pacemaker, implantable cardioverter...
  • ✗Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
See the full criteria
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.

Where Is This Study? (3 UK sites)

Research Site

Harefield UB9 6JH, United Kingdom

WITHDRAWN

Research Site

London W1T 6AH, United Kingdom

Recruiting

Research Site

Manchester M23 9QZ, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09