A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
BREEZE
A Phase II Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
1 other identifier
interventional
84
1 country
40
Brief Summary
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2026
CompletedStudy Start
First participant enrolled
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 6, 2028
August 19, 2026
June 1, 2026
1.6 years
June 24, 2026
August 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized rate of exacerbations over a variable follow-up time
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
Min 28 weeks, max 52 weeks
Secondary Outcomes (7)
Annualized rate of severe exacerbations over a variable follow-up time
Min 28 weeks, max 52 weeks
Change from baseline in QoL-B-RSS
Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
Over the observation period (Week 0 to Last Dose+4 weeks)
Time to first moderate or severe exacerbation
Time Frame: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
At specified timepoints between Week 0 and Final Dose +12 weeks
- +2 more secondary outcomes
Study Arms (2)
AZD0292
EXPERIMENTALAZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Placebo
PLACEBO COMPARATORPlacebo administered starting on Day 1, subsequent administrations per schedule of assessments.
Interventions
Eligibility Criteria
You may qualify if:
- Participant must be ≥ 18 years of age at the time of signing the informed consent/assent.
- Weight ≥ 35 kg.
- 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.
- Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
- Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
- Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
- Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
- Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.
- Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
You may not qualify if:
- 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
- Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
- AIDS or Advanced human immunodeficiency virus disease (CD4 count of \< 200 cells/mm3)
- History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
- Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
- Chronic immunosuppressive therapy (including prednisolone \> 5 mg or equivalent) newly initiated within the last 3 months
- Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
- Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, prior to screening.
- Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Research Site
Anyang, 455099, China
Research Site
Beijing, 100020, China
Research Site
Beijing, 100034, China
Research Site
Beijing, 100730, China
Research Site
Changsha, 410005, China
Research Site
Chengdu, 610014, China
Research Site
Chengdu, 610078, China
Research Site
Chengdu, 611130, China
Research Site
Chizhou, 247099, China
Research Site
Haikou, 570311, China
Research Site
Hefei, 230061, China
Research Site
Hohhot, 010010, China
Research Site
Hohhot, 010050, China
Research Site
Jinan, 250013, China
Research Site
Jinhua, 321000, China
Research Site
Jining, 272006, China
Research Site
Kunming, 650032, China
Research Site
Langfang, 065000, China
Research Site
Linhai, 317000, China
Research Site
Liuzhou, 545006, China
Research Site
Nanchang, 330000, China
Research Site
Nanchang, 330006, China
Research Site
Nanning, 530021, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200065, China
Research Site
Shanghai, 200080, China
Research Site
Shanghai, 200240, China
Research Site
Shanghai, 201199, China
Research Site
Shenyang, 110004, China
Research Site
Taicang, 215400, China
Research Site
Taizhou, 318000, China
Research Site
Wenzhou, 325000, China
Research Site
Xinxiang, 453100, China
Research Site
Xuzhou, 221000, China
Research Site
Zaozhuang, 277102, China
Research Site
Zhangzhou, 363099, China
Research Site
Zhengzhou, 450000, China
Research Site
Zhengzhou, 450006, China
Research Site
Zhuzhou, 412007, China
Research Site
Zibo, 255036, China
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
August 19, 2026
Study Start
June 24, 2026
Primary Completion (Estimated)
January 18, 2028
Study Completion (Estimated)
June 6, 2028
Last Updated
August 19, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.