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RecruitingPHASE2INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
435
Start
06 Nov 2025
Estimated completion
14 Jun 2028

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.

  1. Are you 12 years old or older and weigh at least 35 kg?
  2. Do you have bronchiectasis confirmed by a scan?
  3. Has Pseudomonas aeruginosa been found in your lungs recently?
  4. Have you had at least two flare-ups needing antibiotics in the last year?
  5. Are you generally stable in your bronchiectasis right now?
  6. Do you not need long-term oxygen therapy for your breathing?
Answer every question to see your result.

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

Taking part in any study has potential benefits and risks. A potential benefit of this study is that AZD0292 might reduce the number of severe lung flare-ups you experience, which could improve your lung health and quality of life. However, as this is a new medicine, there's always a chance it may not work for you, or it could cause side effects that we don't fully know about yet. These could include reactions at the injection site or other effects on your body. You will be closely monitored for any reactions or side effects. Remember, joining this study is entirely your choice, and you are free to leave at any time without giving a reason, and it will not affect your usual medical care.

Locations (185)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Orange, United States· Recruiting
  • Research Site
    Verified postcode
    San Francisco, United States· Recruiting
  • Research Site
    Verified postcode
    Denver, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Washington D.C., United States· Recruiting
  • Research Site
    Verified postcode
    Jacksonville, United States· Recruiting
  • Research Site
    Verified postcode
    Miami Lakes, United States· Suspended
  • Research Site
    Verified postcode
    Naples, United States· Recruiting
  • Research Site
    Verified postcode
    Ormond Beach, United States· Recruiting
  • Research Site
    Verified postcode
    Plantation, United States· Recruiting
  • Research Site
    Verified postcode
    Rincon, United States· Recruiting
  • Research Site
    Verified postcode
    Kansas City, United States· Recruiting
  • Research Site
    Verified postcode
    Ann 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?

Register your interest

Share your details and the research team for "A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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