Vigilant COPD Study

About COPD (Chronic Obstructive Pulmonary Disease)
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, and studies like this one help us develop them.

About the investigational medication
This study is assessing an investigational biologic medication, given as an injection, for the treatment of moderate to severe COPD. “Biologic” simply 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 contributes to lung inflammation, called eosinophils (eo-sin-o-fils), and reduce their number. By “investigational,” we mean that this medication has not yet been approved for public 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 to placebo (an injection with no medicine) when used as add-on therapy to the medications you are currently taking for your COPD. Researchers also want to assess the safety of the investigational medication in this population.

Rescue medicines will also be provided for use during the study. 

The main purposes of the study are:

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

Reason to participate
Your involvement in this study may help advance scientific knowledge that could contribute to the development of a new medication and better treatment for people with COPD in the future. Other reasons to participate include:

Taking part in the study involves, first, meeting with the research doctor to learn 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 1 to 3 years, depending on when you enrol.

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. Not all health checks are done at all visits.  We would like to ask you questions about your COPD, medical history and general health.

Other procedures include:

• Vital signs, blood & urine tests for screening your health
• Pregnancy testing (if applicable)
• Electrocardiograms (ECGs) to check heart function
• Lung function tests (spirometry)
• Fractional exhaled nitric oxide (FeNO) test
• Nasal brushing and nasal lining fluid samples (selected visits)
• Study drug injections given [II5.1][CB5.2] at the clinic
• Quality of life assessments and daily symptom diary completion to see how you are feeling
• Additional biomarker testing
• Genetic testing (if consented)

You would take the investigational medicine or a placebo, whereby if you consent to participate in the study and meet all of the eligibility criteria, you will be randomized (like the flip of a coin) to either the investigational medication or placebo (a solution that looks like the active investigational medication but contains no active medication) 50% of participants will receive the active medication while 50% will receive placebo.