Bronchiectasis With Pseudomonas Aeruginosa ColonizationPhase 2BREEZENCT07774403
A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
A Phase 2 study testing AZD0292 in people with Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by AstraZeneca at 40 sites in China.
Trial summary
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis With Pseudomonas Aeruginosa Colonization
- What is being tested?
- AZD0292
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 40 sitesChina
- Study dates
- 24 Jun 2026to 6 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
40 sites in 1 country
China40 sites, 40 recruiting
- Recruiting
Research Site
Anyang, 455099
- Recruiting
Research Site
Beijing, 100020
- Recruiting
Research Site
Beijing, 100034
- Recruiting
Research Site
Beijing, 100730
- Recruiting
Research Site
Changsha, 410005
- Recruiting
Research Site
Chengdu, 610014
- Recruiting
Research Site
Chengdu, 610078
- Recruiting
Research Site
Chengdu, 611130
- Recruiting
Research Site
Chizhou, 247099
- Recruiting
Research Site
Haikou, 570311
- Recruiting
Research Site
Hefei, 230061
- Recruiting
Research Site
Hohhot, 010010
- Recruiting
Research Site
Hohhot, 010050
- Recruiting
Research Site
Jinan, 250013
- Recruiting
Research Site
Jinhua, 321000
- Recruiting
Research Site
Jining, 272006
- Recruiting
Research Site
Kunming, 650032
- Recruiting
Research Site
Langfang, 065000
- Recruiting
Research Site
Linhai, 317000
- Recruiting
Research Site
Liuzhou, 545006
- Recruiting
Research Site
Nanchang, 330000
- Recruiting
Research Site
Nanchang, 330006
- Recruiting
Research Site
Nanning, 530021
- Recruiting
Research Site
Shanghai, 200032
- Recruiting
Research Site
Shanghai, 200065
- Recruiting
Research Site
Shanghai, 200080
- Recruiting
Research Site
Shanghai, 200240
- Recruiting
Research Site
Shanghai, 201199
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Taicang, 215400
- Recruiting
Research Site
Taizhou, 318000
- Recruiting
Research Site
Wenzhou, 325000
- Recruiting
Research Site
Xinxiang, 453100
- Recruiting
Research Site
Xuzhou, 221000
- Recruiting
Research Site
Zaozhuang, 277102
- Recruiting
Research Site
Zhangzhou, 363000
- Recruiting
Research Site
Zhengzhou, 450000
- Recruiting
Research Site
Zhengzhou, 450006
- Recruiting
Research Site
Zhuzhou, 412007
- Recruiting
Research Site
Zibo, 255036
About this study
Official title: 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
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Read the detailed description
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
This Phase II study aims to assess the efficacy, safety, and PK of AZD0292 administered IV, as compared to placebo in participants 18 years of age and older.
The population of this study will be Chinese NCFBE patients with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options.
- Being tested
- AZD0292, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0292Drug
AZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
PlaceboOther
Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.
| Study group | Role | What they receive |
|---|---|---|
| AZD0292 | Experimental | AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. Receives: Drug: AZD0292 |
| Placebo | Placebo comparator | Placebo administered starting on Day 1, subsequent administrations per schedule of assessments. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Min 28 weeks, max 52 weeks
Secondary outcomes (7)
Annualized rate of severe exacerbations over a variable follow-up time
To evaluate the effect of AZD0292 compared to placebo on severe exacerbations in participants with NCFBE and chronic colonization with PsA
Measured: Min 28 weeks, max 52 weeks
Change from baseline in QoL-B-RSS
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period
Measured: Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.
Measured: Over the observation period (Week 0 to Last Dose+4 weeks)
Time to first moderate or severe exacerbation
To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
Measured: Time Frame: Through study completion (Final Dose +24 weeks)
Serum Concentrations
To evaluate AZD0292 serum concentrations following IV dosing in participants with bronchiectasis and chronic colonization with PsA
Measured: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of ADA and ADA titers to AZD0292
To evaluate the immunogenicity of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
Measured: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of AEs, SAEs, AESIs and MAAEs
To assess the safety of AZD0292 compared with placebo in participants with bronchiectasis and chronic colonization with PsA
Measured: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start24 Jun 2026
- Primary completion18 Jan 2028 (estimated)
- Study completion6 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis With Pseudomonas Aeruginosa ColonizationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774403
- Sponsor's protocol ID
- D7700C00010
- Acronym
- BREEZE
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07774403
- Acronym / sponsor ID
- BREEZE / D7700C00010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 18 Jan 2028 (estimated)
- Study completion
- 6 Jun 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
Detailed description
AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.
This Phase II study aims to assess the efficacy, safety, and PK of AZD0292 administered IV, as compared to placebo in participants 18 years of age and older.
The population of this study will be Chinese NCFBE patients with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD0292 | Experimental | Drug: AZD0292AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered starting on Day 1, subsequent administrations per schedule of assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0292AZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments. | Drug | AZD0292 |
| PlaceboPlacebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments. | Other | Placebo |
Primary outcome
Annualized rate of exacerbations over a variable follow-up time
Time frame: Min 28 weeks, max 52 weeks
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
7 secondary outcomes
Annualized rate of severe exacerbations over a variable follow-up time
Time frame: Min 28 weeks, max 52 weeks
Change from baseline in QoL-B-RSS
Time frame: Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
Time frame: Over the observation period (Week 0 to Last Dose+4 weeks)
Time to first moderate or severe exacerbation
Time frame: Time Frame: Through study completion (Final Dose +24 weeks)
Serum Concentrations
Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of ADA and ADA titers to AZD0292
Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks
Incidence of AEs, SAEs, AESIs and MAAEs
Time frame: Occurrence of AEs; first dose through 12 weeks after last study intervention administration. Occurrence of SAEs, AESIs, and MAAEs; through study completion (Final Dose+24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0292 in people with Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by AstraZeneca at 40 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of exacerbations over a variable follow-up time (time frame: Min 28 weeks, max 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.