A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose I… (NCT07073950) | Clinical Trial Compass
RecruitingPhase 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
Germany, United Kingdom56 participantsStarted 2025-11-24
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
*…
What they're measuring
1
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)