THESEUS COPD Study

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition that makes breathing increasingly difficult due to damaged airways and air sacs, causing symptoms like persistent cough, excess mucus, shortness of breath, and wheezing. It's primarily caused by long-term exposure to cigarette smoke or other lung irritants and affects approximately 15% of New Zealanders over 45 years old. The disease involves periods of stability interrupted by "exacerbations" or flare-ups where symptoms suddenly worsen, often requiring urgent medical care.

Standard treatment in New Zealand follows a stepwise approach starting with bronchodilator inhalers (like Spiriva or Symbicort) that open airways, progressing to combination inhalers containing steroids for those with frequent flare-ups, with additional options including pulmonary rehabilitation programs and oxygen therapy for severe cases. While these treatments help manage symptoms and slow progression, many patients continue to experience frequent exacerbations despite optimal inhaler therapy, highlighting the need for new treatment approaches like the biologics being tested in this study.

About the Investigational Medication
The study drug is a new type of injectable medication being tested for COPD that works differently from traditional inhalers. It's a "biologic" therapy - a medication made from living cells that targets specific proteins in your body causing lung inflammation.

Unlike inhalers that mainly open airways, the study drug blocks two key inflammatory proteins (TSLP and IL-13) that trigger COPD flare-ups in people with high eosinophil counts. Think of it as turning off the "alarm signals" that cause your lungs to overreact and become inflamed.

The medication is given as a small injection under the skin every 4 or 8 weeks at the clinic, similar to how some people receive diabetes or arthritis medications.

Study Aim
The main purpose of the study is to evaluate whether the study medication can reduce the frequency of moderate-to-severe COPD exacerbations (flare-ups) and improve lung function, COPD symptoms, and quality of life when added to standard controller medications.

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:

• Access to a potential new treatment targeting the underlying inflammation in COPD
• Close monitoring by COPD specialists throughout the study
• All study-related care and medication provided at no cost
• Potential for reduced exacerbations and improved breathing
• Opportunity to continue in a long-term safety study if eligible
  
  

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 you are eligible, we would like to see you for 16 clinic visits over a period of around 44 weeks (14 months).

At the visits, we undertake health checks which can include physical examinations and blood tests. We would like to ask you questions about your general health and your COPD experience. Other procedures throughout the study include:

• Vital signs
• ECG’s
• Pregnancy testing
• Urine tests
• Biomarker blood tests (some may require fasting)
• Spirometry
• Lung tests
• Nasal swabs
• Subcutaneous injections every 4 or 8 weeks (depending on treatment group)
• Regular electronic diary (eDiary) and questionnaire completion
• Optional genetic testing (DNA/RNA analysis)

You would take the potential new medication or a or placebo (looks like the investigational medicine but contains no active medication). Neither participants nor study staff know who receives active drug vs. placebo. Participants receiving placebo still benefit from:

• Close medical monitoring
• Regular lung function testing
• Prompt treatment of exacerbations
• Access to all study assessments at no cost

The study medication is taken as subcutaneous injection, meaning that it is taken as an injection under the skin (usually in the abdomen, thigh, or upper arm) every 4 or 8 weeks. The study drug is administered by trained study staff at the clinic (it is not self-administered).

The study aims to investigate the study medication and to show that it can significantly reduce the annual rate of moderate-to-severe COPD exacerbations (flare-ups) compared to placebo in adults with eosinophilic COPD. The study would also like to evaluate whether the study drug improves lung function, reduces COPD symptoms, enhances quality of life and test whether it is well tolerated over 48 weeks.