A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

To be considered for this study, you need to be between 40 and 80 years old. You must have a confirmed diagnosis of COPD. You should also have a history of smoking for at least 10 'pack-years', which means how much you've smoked over your lifetime. If you've quit smoking, you need to have stopped at least six months before starting the study.

An important part of this study is that you must also be at a higher risk of heart or lung problems. This could mean you already have a heart condition, or you have risk factors like high blood pressure, diabetes, kidney disease, high cholesterol, or obesity. The study will also check your blood for a certain type of white blood cell, called eosinophils, and your score on a questionnaire about your COPD symptoms must be 10 or higher.

There are also reasons why you might not be able to join. For example, if you've been diagnosed with asthma in the last five years, or if you had childhood asthma that has continued into adulthood, you would not be eligible. The medical team will check all these details to see if this study is right for you.

If you join this study, it will run for quite a long time, potentially several years, because researchers need to see how the inhalers affect your health over time. You'll use either the new 'triple therapy' inhaler or the 'dual therapy' inhaler twice a day. You won't know which one you're receiving, and neither will your local study doctor – this is called a 'double-blind' study and helps ensure the results are unbiased.

You will have regular appointments at the study clinic or virtual visits, as decided by the study team. During these visits, the team will check how your lungs are working, measure your blood pressure, and take blood samples. They'll also ask you questions about your health and any symptoms you might be experiencing. It's really important that you can reliably use an inhaler correctly and are willing to follow all the study instructions regarding your medications and visits.