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A study to evaluate the safety and effectiveness of AZD0292 in people aged 12 years and older with bronchiectasis and chronic Pseudomonas aeruginosa infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Bronchiectasis, a condition where the airways in the lungs become permanently widened and damaged, making it difficult to clear mucus. This condition is often complicated by Pseudomonas aeruginosa colonization, which occurs when a specific type of bacteria lives in the airways for a long time. The purpose of the study is to evaluate the effectiveness and safety of a medication called AZD0292. This treatment is provided as a solution for infusion, which means it is delivered directly into the bloodstream through a needle or tube.

During the trial, participants are assigned to receive either AZD0292 or a placebo. The study is double-blind, meaning that neither the participants nor the researchers know which treatment is being administered until the study is finished. The research will monitor how the medication moves through the body, a process known as pharmacokinetics, and track any pulmonary exacerbations, which are sudden increases in symptoms like coughing or shortness of breath. Participants will be monitored over a period of time to observe how the treatment affects the frequency of these lung symptom flare-ups.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The trial begins with the administration of either AZD0292 or a placebo, which is an inactive substance used for comparison.

    The AZD0292 is provided as a solution for infusion, meaning it is delivered directly into a vein through a medical tube.

  2. Step 2

    Monitoring and evaluation

    The study monitors the annualized rate of exacerbations, which refers to how often lung symptoms become moderate or severe.

    Blood samples are collected to measure serum pk concentrations, which tracks how the medication moves through the body over time.

    Blood tests also check for ADA, which stands for anti-drug antibodies, to see if the body develops a reaction to the medication.

    The impact on quality of life is assessed through specific scoring systems to track changes from the start of the trial.

    adverse events, which are any unexpected medical occurrences or side effects, are recorded from the first dose through 12 weeks after the final dose of the medication.

Who can join the trial?

11 criteria

  • You must be at least 18 years old when you sign the study agreement.
  • Your weight must be 35 kilograms (about 77 pounds) or more.
  • A doctor must have diagnosed you with bronchiectasis, which is a condition where the airways in your lungs become widened and damaged. This must be confirmed by a CT scan (a special type of X-ray image) showing abnormal widening in at least one part of the lung.
  • You must be receiving the standard of care, which means the usual medical treatments recommended by doctors for your condition.
  • You must have a history of at least two moderate flare-ups (sudden worsening of symptoms) or one severe flare-up in the last 12 months that required antibiotics (medicine used to fight bacterial infections).
  • You must be clinically stable, meaning your condition is steady and you have not had a lung flare-up for at least 4 weeks before being assigned to a study group.
  • Your FEV1, which is a test that measures how much air you can forcefully exhale in one second, must be at least 25% of the expected value for someone of your age and size.
  • You must have tested positive for Pseudomonas aeruginosa (PsA), a type of bacteria, in your airways through a culture (growing bacteria in a lab) or PCR test (a test that looks for the bacteria's genetic material) at least once in the last 24 months.
  • You must have a positive test for the PsA bacteria in your sputum (the thick mucus you cough up from your lungs) within 5 weeks before starting the study.
  • Even if you have previously tried treatments to get rid of the PsA bacteria, you can still join if the bacteria are still present in your system.
  • You must be able to understand and sign an informed consent form, which is a document that explains all the details, rules, and risks of the study.

Who cannot join the trial?

12 criteria

  • Having a main lung condition that is not bronchiectasis, which is a long-term disease where the airways in the lungs become widened and damaged.
  • Using any experimental medicines intended to treat or prevent lung flare-ups, or planning to use them during the study.
  • People with Cystic Fibrosis (a genetic disorder affecting the lungs and digestive system) who started CFTR modulator therapies, which are drugs that help improve how certain proteins work in the body, within the last 3 months.
  • Female participants who are pregnant, breastfeeding, or could become pregnant and are not using a very reliable form of contraception (birth control) or practicing abstinence.
  • Having tuberculosis (a serious infection caused by bacteria) or nontuberculous mycobacteria (a group of bacteria that can cause lung infections) that is currently being treated or needs treatment.
  • Having allergic bronchopulmonary aspergillosis, which is an allergic reaction to a specific type of fungus in the lungs, that is currently being treated or needs treatment.
  • Needing to use supplemental oxygen for long periods, though using oxygen for walking or to help with shortness of breath after exercise is allowed.
  • Having malignancy, which is another word for cancer, that is current or occurred within the last 5 years. This does not include stable prostate cancer, certain skin cancers, or specific types of cervical cancer that were successfully treated.
  • Having AIDS or advanced human immunodeficiency virus (HIV) disease, specifically a CD4 count (a measure of immune system cells) of less than 200 cells/mm3.
  • A history of severe allergic reactions to monoclonal antibodies, which are laboratory-made proteins used to treat diseases, including anaphylaxis (a life-threatening allergic reaction) or immune complex disease (a condition where the immune system attacks the body's own tissues).
  • Starting long-term antibiotics used to treat PsA (a specific type of bacteria), macrolides (a type of antibiotic), or DPP-1 inhibitors (a type of medicine) within the last 3 months.
  • Starting long-term immunosuppressive therapy, which are medicines that lower the body's ability to fight infection, such as prednisolone, within the last 3 months.
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Investigated drugs

AZD0292 is an experimental medicine given through an IV drip to help treat people with bronchiectasis and a long-term infection of a specific bacteria called Pseudomonas aeruginosa. This study is testing how well this medicine works to reduce the frequency of serious lung flare-ups.

What is already known about the treatment

AZD0292 - This medication is an experimental drug administered as a liquid through an intravenous infusion into a vein. Currently being studied in clinical trials, it is being investigated as a potential treatment for people with bronchiectasis who have a long-term infection with certain bacteria in their lungs. It works at a molecular level by targeting and inhibiting a specific protein that helps bacteria survive and grow, making it a type of targeted antibiotic therapy. Placebo for AZD0292 - A placebo is an inactive substance that is not a real medication and contains no active ingredients. In this clinical trial, it is used as a control to compare against the experimental drug to see if the treatment truly works. It is administered in a way that mimics the actual drug to ensure the study remains fair and unbiased.

Investigated diseases

Bronchiectasis with chronic pseudomonas aeruginosa colonization - This condition occurs when the airways in the lungs become permanently widened and damaged. This damage makes it difficult for the lungs to clear mucus, which can lead to frequent infections. In this specific case, a certain type of bacteria called pseudomonas aeruginosa stays in the airways over a long period. The presence of this bacteria can cause repeated flare-ups of lung symptoms. As the condition progresses, the buildup of mucus and bacteria can lead to increasing inflammation in the respiratory tract.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523009-14-00Protocol codeD7700C00003Estimated enrolment435 patientsSponsorAstraZeneca AB

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