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Compares treatment options for Chronic Obstructive Pulmonary Disease
Official title 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
ClinicalTrials.gov ID: NCT07073950
What this study is testing
What is Budesonide/Glycopyrronium/Formoterol Fumarate?
Budesonide/Glycopyrronium/Formoterol Fumarate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic obstructive pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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/mm³ in the past 12 months.
- At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
You likely can't join if
- A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency...
- 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...
- Participants with ECG QTcF interval at Visit 1 \> 460 milliseconds (ms) for males and \> 480 ms for females.
See the full eligibility 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/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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ahrensburg, Germany
- Berlin, Germany
- Frankfurt, Germany
- Hanover, Germany
- Harefield, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahrensburg, Germany; Berlin, Germany; Frankfurt, Germany; Hanover, Germany; Harefield, United Kingdom; London, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.