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

To join this study, participants generally need to be between 40 and 80 years old and have a history of smoking for at least 10 years, even if you've stopped. You must have a confirmed diagnosis of COPD, where your breathing tests show specific patterns. We'll also check your lung function closely, including how much air your lungs can hold, as well as checking your blood for certain cell counts.

You should currently be using a regular inhaler treatment for your COPD, whether it's one, two, or three different medications. If you're a woman, you'll need to either be past childbearing age or using very effective contraception, and we'll do a pregnancy test to be sure.

There are also some reasons why you might not be able to join. For example, if you've been diagnosed with asthma, or other serious lung conditions like lung cancer or sarcoidosis. We can't include you if you've recently had a severe COPD flare-up needing hospital treatment or multiple flare-ups needing steroid tablets. Also, if you have certain heart conditions, such as a history of heart attack, irregular heartbeats, or a heart device like a pacemaker, you won't be able to participate. We'll also need to check your heart tracing (ECG) to ensure no significant electrical issues.

If you decide to take part, the study starts with a screening visit to check if you meet all the requirements. Before being randomly assigned to a treatment group, you'll use a placebo inhaler and another standard reliever inhaler (salbutamol) for a short period.

Following this, there will be two main treatment periods, each lasting 21 days. In one period, you'll use the BGF MDI inhaler, and in the other, you'll use a matching dummy inhaler (placebo). The order in which you receive these will be chosen by chance, like flipping a coin. Neither you nor the study team will know which inhaler you're using at any given time, which helps ensure the results are fair and unbiased.

Throughout these periods, you'll have several visits to the study clinic for assessments of your heart and lung function, which might include breathing tests and heart tracings. After both treatment periods are completed, there will be a final follow-up visit. The total duration of your involvement in the study will be discussed with you during the initial screening.