A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
This study is looking into a new medicine called AZD0292 for people aged 12 and over who have a lung condition called bronchiectasis. This medicine is designed to help those whose lungs are often affected by an infection called Pseudomonas aeruginosa. The main goal is to find out if AZD0292 can prevent 'exacerbations' – that's when your lung symptoms suddenly get much worse. Researchers will also check how safe the medicine is and how the body handles it, comparing it to a dummy medicine (placebo). This research is important because frequent flare-ups can worsen lung health and affect daily life.
At a glance
What is this study about?
This study is about a new medicine, AZD0292, for people living with bronchiectasis. Bronchiectasis is a long-term lung condition where your airways become widened and scarred, making it harder to clear mucus. This can lead to frequent lung infections, and one very common one is caused by a germ called Pseudomonas aeruginosa. For many people with bronchiectasis, this particular infection keeps coming back, causing symptoms to flare up.
When your bronchiectasis flares up, it means your symptoms like coughing, breathlessness, and phlegm production get much worse. These flare-ups often need strong antibiotics and can be quite serious, sometimes even leading to hospital stays. Over time, these frequent flare-ups can damage your lungs further, make everyday life harder, and, unfortunately, can even shorten your life. Because of this, doctors and researchers are always looking for new ways to prevent these serious flare-ups.
This study, called a Phase IIb study, wants to see if AZD0292 can help stop these flare-ups from happening. It’s a comparison study, meaning some people will get the active medicine, while others will get a placebo (a dummy medicine with no active ingredients). This helps researchers understand whether any improvements or side effects are truly due to the new medicine. The team will also closely monitor safety and how the body processes the medicine to ensure it's suitable for future use.
Key takeaways
- Tests a new medicine (AZD0292) for bronchiectasis.
- Aims to reduce lung flare-ups caused by Pseudomonas aeruginosa infection.
- Compares AZD0292 to a placebo (dummy medicine).
- For people aged 12 and over with specific bronchiectasis criteria.
- Will assess both effectiveness and safety of the new medicine.
- Participation involves regular clinic visits and tests.
Who may be eligible?
To join this study, you need to be at least 12 years old and weigh at least 35 kilograms. You must have a diagnosis of bronchiectasis that has been confirmed by a scan of your chest. A key part of the study is for people who have been living with the Pseudomonas aeruginosa infection in their lungs, meaning it's been found in your airways at least once in the last two years and again recently.
Your bronchiectasis should be stable when you join, meaning you haven't had a flare-up requiring antibiotics for at least four weeks. You should also be receiving the usual care for your bronchiectasis and have experienced at least two moderate flare-ups or one severe flare-up needing antibiotics in the past year. Your lung function, measured by a breathing test, needs to be at a certain level.
There are some reasons why you might not be able to join. For example, if you have other main lung conditions apart from bronchiectasis, or if you have active tuberculosis or certain fungal infections in your lungs that are being treated. Generally, if you need long-term oxygen therapy for breathlessness, you wouldn't be able to participate, though using oxygen for activity is usually fine. You also can't have certain serious illnesses like active cancer.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 12 years old or older and weigh at least 35 kg?
- Do you have bronchiectasis confirmed by a scan?
- Has Pseudomonas aeruginosa been found in your lungs recently?
- Have you had at least two flare-ups needing antibiotics in the last year?
- Are you generally stable in your bronchiectasis right now?
- Do you not need long-term oxygen therapy for your breathing?
What does participation involve?
If you decide to join this study, you would receive the study medicine, AZD0292, or a placebo (a dummy medicine), given directly into a vein (intravenously). This would happen at certain times throughout the study. You would have regular visits to the study clinic where the research team would check your health, do physical exams, and take blood and urine samples. You'd also have breathing tests, and your sputum (phlegm) would be checked regularly to see if the Pseudomonas aeruginosa infection is present. You would be asked to keep track of your symptoms and any changes in your health in a diary. These visits help the researchers understand how the medicine is working and whether it's safe. The study will last for a specific period, and more details on the exact number and timing of visits would be explained fully by the study team.
Potential risks and benefits
Locations (185)
- Research SiteVerified postcodeOrange, United States· Recruiting
- Research SiteVerified postcodeSan Francisco, United States· Recruiting
- Research SiteVerified postcodeDenver, United States· Not yet recruiting
- Research SiteVerified postcodeWashington D.C., United States· Recruiting
- Research SiteVerified postcodeJacksonville, United States· Recruiting
- Research SiteVerified postcodeMiami Lakes, United States· Suspended
- Research SiteVerified postcodeNaples, United States· Recruiting
- Research SiteVerified postcodeOrmond Beach, United States· Recruiting
- Research SiteVerified postcodePlantation, United States· Recruiting
- Research SiteVerified postcodeRincon, United States· Recruiting
- Research SiteVerified postcodeKansas City, United States· Recruiting
- Research SiteVerified postcodeAnn Arbor, United States· Not yet recruiting
Common questions
What is an 'exacerbation'?
An exacerbation is when your lung symptoms, like coughing or breathlessness, suddenly get much worse and usually need antibiotics.
What is 'Pseudomonas aeruginosa'?
It's a common type of bacteria that can cause lung infections, especially in people with bronchiectasis.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It helps researchers compare results.
How will the medicine be given?
The medicine, or placebo, will be given directly into a vein, called an IV infusion.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without it affecting your medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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