ENDURA COPD Study

COPD is a chronic lung condition that makes it difficult to breathe and typically gets worse over time. It includes emphysema and chronic bronchitis and is usually caused by long-term exposure to irritants like cigarette smoke. People with COPD experience symptoms such as shortness of breath, persistent cough, excess mucus production, and wheezing. The disease is punctuated by “exacerbations” or flare-ups where symptoms suddenly worsen, often requiring urgent medical care, steroids, or hospitalisation.

There are different types of COPD. For example, up to 40% have what’s called “Type 2 inflammation,” which may increase the risk of symptom flare-ups. Though there is no cure for COPD, medications exist to help make breathing easier. Even so, more targeted treatments are needed — especially for those with Type 2 inflammation — and studies like this one help us develop them.

About the Investigational Medication
This study is assessing an investigational medication — a type of biologic medicine given as subcutaneous injections — for the treatment of moderate to severe COPD. “Biologic” means that it is derived from a living thing (like cells) as opposed to being a man-made chemical. In this case, the investigational drug has been designed to target a specific cell type (that causes inflammation in the lungs) and reduce their number. By “investigational,” we mean that this medication has not been approved for general use.

The main goals of the study are to determine whether the investigational medication can reduce the number of moderate/severe exacerbations and improve symptoms and quality of life compared with placebo (shots with no medicine) when used as add-on therapy. Researchers also want to assess how safe the investigational medication is in this population.

Investigational medication will be given as an add-on therapy to your current COPD medications. Rescue medicines will also be provided for use during the study.

Study Aim
The primary purposes of the study are:

• To see if the investigational medication can lower the number of moderate/severe exacerbations (symptom flare-ups)
• To improve symptoms and quality of life compared to placebo when used as add-on therapy.
• To assess how safe the investigational medication is in the COPD population.

About the Study
Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you.  If you wish to take part and are eligible, we would like to see you for a minimum of 18 study visits and up to 30 over a period of (Minimum) 1 year to (maximum) 2 years.

Note: Some visits between main clinic visits can be done remotely by phone or video call for your convenience.

During clinic visits, we conduct health checks that may include physical examinations and blood tests. We would like to ask you questions about your COPD and your general health. Other procedures throughout the study may include:

• Study drug administration: 4 Study drug injections (every 26 weeks) given under the skin at clinic
• Lung infection tests: Spirometry breathing assessment tests
• Heart monitoring: ECG to check heart function
• Blood tests:  Blood draws for testing/screening your health
• Questionnaires: Various questionnaires/assessments to see how you are feeling
  
  

You would take the potential new medication or a placebo (looks like the investigational medicine but contains no active medication). The study medication is administered as a subcutaneous injection, meaning it is injected into the subcutaneous tissue.