BRONCO Bronchiectasis Study

Bronchiectasis is a lung disease that usually results from an infection or other condition that injures the walls of the airways in your lungs. This injury marks the beginning of a cycle in which your airways slowly lose their ability to clear mucus, leading to mucus buildup and an environment where bacteria can grow. This leads to repeated serious lung infections that further damage your airways. Over time, the airways become stretched out, flabby, scarred and unable to move air in and out. Bronchiectasis usually begins in childhood, but symptoms may not appear until months or even years after you have started having repeated lung infections.

About the Investigational Medication
The study medication is given as a subcutaneous injection administered at the clinic by healthcare practitioners. Participants will either receive 2-4 doses total, every 12 weeks, depending on when they enrol. Participants are monitored for at least 3 hours after each injection for safety.

The study medication is an investigational monoclonal antibody therapy - a type of biological medication designed to work with your immune system. The study medication blocks IL-33, a protein that triggers lung inflammation in people with bronchiectasis. When lung tissue is damaged or stressed, it releases IL-33, triggering a cascade of inflammatory responses that lead to increased mucus production, airway damage, and infections. By blocking IL-33 with an injection every 12 weeks, this therapy aims to break the cycle of inflammation and infection that characterises bronchiectasis.

The medication is still being tested and is not yet approved, but it represents a new approach that targets the underlying inflammatory problem rather than just treating infections after they happen.

The main purpose of this study is to learn about an investigational antibody therapy targeting IL-33, a protein involved in lung inflammation. The medication is given as an injection under the skin every 12 weeks. The aim of this study is to evaluate whether the potential new therapy can reduce lung inflammation (exacerbations) and improve quality of life in people with bronchiectasis compared to a placebo. The study will also assess safety, lung function, and the body's pharmacokinetics.

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 bronchiectasis in the future. Other reasons to participate include:
Regular health assessments, including lung function tests and imaging
Health monitoring by highly specialised NZ Doctors and Nurses
Study care is provided at no cost
Reimbursement for time and travel

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 13-15 clinic visits over 48-82 weeks (about 11-19 months), depending on when you enrol.

During visits, we conduct health checks that may include physical examinations and blood tests. We would like to ask you questions about your bronchiectasis, medical history and general health. Other procedures include:

• Vital signs & urine tests
• Nasal swabs & samples (select visits)
• Pregnancy testing (if applicable)
• Electrocardiograms (ECGs)
• HRCT scan (specialised lung imaging)
• Lung function tests (spirometry) before and after bronchodilator
• Sputum sample collection
• Quality of life assessments and daily symptom diary completion
• Additional biomarker testing
• Genetic testing (if consented)