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Bronchiectasis and Pseudomonas Aeruginosa Colonization Prevention Study for AZD0292 in Participants 12 and Older

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Study AimThis study aims to prevent bronchiectasis and Pseudomonas aeruginosa colonization in individuals aged 12 and above using AZD0292. It will assess how many moderate-to-severe lung exacerbations occur with AZD0292 compared to a placebo.
What is being tested

AZD0292

+ Placebo
Biological
Other
Who is being recruted

Bronchiectasis With Pseudomonas Aeruginosa Colonization

Over 12 Years
+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled
Phase 2
Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: July 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 12, 2025Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new treatment, AZD0292, for people aged 12 and older who have a lung condition called bronchiectasis and are chronically affected by a bacteria known as Pseudomonas aeruginosa. This bacteria can cause frequent worsening of lung symptoms, which can lead to a decline in lung health, impact daily life, and increase the risk of serious health issues. The study is important because it seeks to find an effective way to prevent these worsening episodes, which could significantly improve the lives of those living with this condition. Additionally, the treatment is also being explored in patients with cystic fibrosis who have similar bacterial colonization. In the study, participants will receive AZD0292 through an intravenous (IV) infusion, which means the medicine is delivered directly into the bloodstream. The study will compare the effects of AZD0292 given in two different doses to a placebo, which is a substance with no active medication. Researchers will look at how well the treatment works, its safety, and how the body processes the drug. While the study will primarily focus on patients with non-cystic fibrosis bronchiectasis, it will also include patients with cystic fibrosis as an exploratory group to understand the potential wider application of the treatment.

Official TitleA Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization 
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: July 28, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
435 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchiectasis With Pseudomonas Aeruginosa Colonization
Criteria
9 inclusion criteria required to participate
Weight ≥ 35 kg
Participant must be ≥ 12 years of age at the time of signing the informed consent/assent
Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
Documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics

Show More Criteria

12 exclusion criteria prevent from participating
Primary lung diagnosis other than bronchiectasis
Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
High-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Group II
Experimental
Low-dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Group III
Placebo
Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.
Study Objectives
Primary Objectives

To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to-severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA.
Secondary Objectives

To evaluate the effect of AZD0292 compared to placebo on severe exacerbations in participants with NCFBE and chronic colonization with PsA

To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period

To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.

To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.

To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA

To evaluate the immunogenicity of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA

To assess the safety of AZD0292 compared with placebo in participants with bronchiectasis and chronic colonization with PsA

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 18 locations
Suspended
Research SiteMansfield, United StatesSee the location
Suspended
Research SiteGent, Belgium
Suspended
Research SiteLeuven, Belgium
Suspended
Research SiteLiege, Belgium
Recruiting soon18 Study Centers