This clinical study focuses on Non-cystic Fibrosis Bronchiectasis, a condition where the airways in the lungs become permanently widened and damaged. The study will test a new inhaled medication called CSL787, which contains human normal immunoglobulin (a type of protein that helps fight infections), compared to a placebo.
The purpose of this research is to evaluate how well CSL787 works in preventing flare-ups of the disease and to determine the most effective dose. The medication will be given through a nebulizer, which is a device that turns liquid medicine into a fine mist that can be inhaled into the lungs. The study will last for up to 12 months.
During the study, participants will be randomly assigned to receive either different doses of CSL787 or a placebo through the nebulizer. The study will monitor how long it takes before participants experience their first disease flare-up and will also track other aspects of their lung health and overall well-being. This is a double-blind study, which means neither the participants nor the doctors conducting the study will know who is receiving which treatment.
1Initial screening
Your eligibility will be evaluated based on the following criteria:
– Age between 18 to 85 years
– Confirmed diagnosis of Non-cystic Fibrosis Bronchiectasis (NCFB) through chest CT scan
– If your chest CT scan is older than 12 months, a new scan will be performed
– Lung function test showing FEV1 greater than 35% of predicted value and at least 1 liter
2Medical history review
Your medical history must include either:
– At least 2 documented chest infections requiring antibiotics in the past year, or
– 1 chest infection requiring antibiotics and a St. George’s Respiratory Questionnaire score above 40
3Treatment phase
You will receive either:
– CSL787 (human normal immunoglobulin) through inhalation using a nebulizer, or
– Placebo solution for inhalation
The treatment will be randomly assigned and neither you nor your doctor will know which treatment you are receiving
4Monitoring phase
During the study, the following will be monitored:
– Time until your first chest infection
– Number of chest infections per year
– Changes in your respiratory symptoms
– Changes in bacteria levels in your sputum
– Any side effects or adverse events
Who Can Join the Study?
Must be aged between 18 and 85 years old
Must have a confirmed diagnosis of Non-cystic Fibrosis Bronchiectasis (NCFB) through a chest CT scan (a special type of X-ray that creates detailed images of your lungs) within the last 12 months before joining the study. If you don’t have a recent scan, one will be done during screening
Must have experienced at least one of these in the past year:
2 or more lung infections requiring treatment with oral or intravenous antibiotics, OR
1 lung infection requiring antibiotics AND a score higher than 40 on a breathing-related quality of life questionnaire (SGRQ)
Must have lung function tests showing:
More than 35% of normal breathing capacity (FEV1 – the amount of air you can forcefully exhale in one second)
Ability to forcefully exhale at least 1 liter of air in one second
Can be taking other medications for NCFB (such as maintenance macrolides or DPP-1 inhibitors), as long as you had at least one infection while taking these medications for 3 or more months at a stable dose
Who Cannot Join the Study?
Age below 18 or above 75 years
Having cystic fibrosis (an inherited condition affecting the lungs and digestive system)
Current pregnancy or breastfeeding
Having a known allergy to immunoglobulins (antibodies used in the treatment)
Active lung infection at the time of screening
Participation in another clinical trial within the last 30 days
History of severe allergic reactions to medical treatments
Significant kidney or liver disease
Current smoking or having quit smoking within the last 6 months
Unable to use a nebulizer properly (a device that turns liquid medicine into a mist for inhalation)
Having received antibiotics for respiratory infection within the last 4 weeks
History of immunodeficiency (weakened immune system)
Major surgery within the last 3 months
Any condition that the study doctor considers would make participation unsafe
CSL787 (human normal immunoglobulin for nebulization) is a medication that is delivered through a nebulizer, which turns the medicine into a fine mist that can be inhaled. This treatment is being studied for people with non-cystic fibrosis bronchiectasis, a condition where the airways become damaged and widened. The medication contains antibodies (immune system proteins) that may help protect against lung infections and reduce inflammation in the airways.
Non-cystic Fibrosis Bronchiectasis – A chronic respiratory condition characterized by permanent widening of the airways (bronchi) in the lungs. In this condition, the airways become damaged and scarred, leading to areas where mucus can accumulate. The damaged airways lose their ability to clear mucus effectively, creating an environment where bacteria can grow. This results in recurring chest infections and inflammation, causing symptoms such as chronic cough with mucus production, shortness of breath, and recurrent chest infections. The condition is distinct from bronchiectasis caused by cystic fibrosis and can be triggered by various factors including previous severe infections or underlying inflammatory conditions.
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