Zion COPD Study

COPD, or chronic obstructive pulmonary disease, is a condition caused by damage to the airways or other parts of the lung, usually caused by smoking or other irritants. This damage leads to inflammation and other problems that block airflow, making it hard to breathe.

COPD can cause coughing that produces large amounts of mucus. It can also cause breathing problems, shortness of breath, chest tightness, and other symptoms. Because COPD is a progressive disease, its symptoms often develop slowly but worsen over time and can limit your ability to do routine activities. Serious COPD may prevent you from doing even basic activities such as walking, cooking, or taking care of yourself.

COPD generally refers to two different diseases: emphysema and chronic bronchitis.

1. Emphysema develops when there is damage to the walls between many of the air sacs in the lungs. Usually, these sacs are elastic or stretchy. When you breathe in, each air sac fills up with air, like a small balloon. When you breathe out, the air sacs deflate, and the air goes out. In emphysema, it is harder for your lungs to move air out of your body.
2. Chronic (long-term) bronchitis is caused by repeated or ongoing irritation and inflammation of the airway lining. A lot of thick mucus forms in the airways, making it hard to breathe.
   
   

Most people who have COPD have a mixture of both emphysema and chronic bronchitis in different proportions, and how serious each condition is varies from person to person.

In New Zealand, treatment includes inhalers to open the airways, help with flare-ups, and reduce symptoms over time. Other helpful steps include quitting smoking, staying active through pulmonary rehab, and keeping up with flu and pneumonia vaccines.

About the Investigational Medication
The investigational medication is administered as a subcutaneous injection (under the skin) by a registered healthcare professional. There are 3 total injection visits over 12 weeks. The study drug is a potential new medicine that blocks a protein in your body that causes inflammation and swelling in your lungs. This inflammation makes it harder for people with COPD to breathe and can worsen their symptoms. By reducing this inflammation, the study drug may help improve breathing and reduce COPD symptoms.

This targeted therapy aims to work differently from traditional COPD medications, addressing the underlying inflammation rather than just symptoms.

Please note that this is an add-on treatment, meaning participants continue their regular COPD medications throughout the study.

Key Points

• This is not a replacement for current COPD medications
• Participants must stay on their existing maintenance COPD therapy
• The study tests whether adding Solrikitug provides additional benefits
• It's a biologic medication like treatments used for other inflammatory conditions like asthma and arthritis

Study Aim

The primary purpose of this study is to learn about the study drug and investigate its ability to reduce inflammatory cells and, if so, how it improves lung function.

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 the same disease in the future.

What does taking part involve?
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 10 clinic visits over up to 32 weeks.

During 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 health and your experience throughout the study. Other procedures undertaken will include:

• Vital signs, urine tests and nasal swabs
• ECG’s
• Breathing and lung function tests
• 3 injection visits
• HRCT scans (if required)
  

You would take the potential new medication or a placebo (looks like the investigational medicine but contains no active medication). 67% (2/3) of participants will receive the study drug, and 33% (1/3) will receive a placebo. The study medication is taken as a subcutaneous injection (under the skin) administered by a registered healthcare professional. There are 3 total injection visits over 12 weeks.