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NCT07073950RecruitingPhase 4

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

A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
56 (estimated)
First submitted
17 Jul 2025
Start date
24 Nov 2025
Primary completion date
31 May 2027
Lead sponsor
AstraZeneca
Diseases
COPD
NCT number
NCT07073950
EU CT number
2025-521987-37-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 56
  • From 24 Nov 2025 to the primary completion date, 31 May 2027
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.

Who 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 (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.

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Velocity Clinical Research Germany GmbH
Coordinator of this site? Confirm its status
AhrensburgGermanyRecruiting
Parexel International GmbH
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
IKF Pneumologie GmbH & Co. KG
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyRecruiting
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
Coordinator of this site? Confirm its status
HanoverGermanyRecruiting
-
Coordinator of this site? Confirm its status
HarefieldUnited KingdomWithdrawn
-
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
-
Coordinator of this site? Confirm its status
ManchesterUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.