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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Ahrensburg | Germany | Recruiting |
| Parexel International GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Harefield | United Kingdom | Withdrawn |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.