ClinicalTrials.gg
RecruitingNCT07774403BREEZEUpdated Oct 8, 2026

A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

A Phase 2 interventional study of AZD0292 and Placebo in Bronchiectasis With Pseudomonas Aeruginosa Colonization, sponsored by AstraZeneca. Recruiting at 40 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by AstraZeneca · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 8, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bronchiectasis With Pseudomonas Aeruginosa Colonization

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03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 84 is above the median of 60 across 263 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be ≥ 18 years of age at the time of signing the /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 ≥ 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • , 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 disease ( 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 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 therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
  • Receipt of 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 and not using a highly effective method of or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    AZD0292

    AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.

    Drug: AZD0292

  • Placebo comparator
    Placebo

    Placebo administered starting on Day 1, subsequent administrations per schedule of assessments.

    Other: Placebo

Interventions

  • AZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

  • OtherPlacebo

    Placebo administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

06

What researchers measure

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

    Time frame: Min 28 weeks, max 52 weeks

Secondary outcomes

  1. 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

    Time frame: Min 28 weeks, max 52 weeks

  2. 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

    Time frame: Over the observation period (Week 0 to Last Dose+4 weeks)

  3. 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.

    Time frame: Over the observation period (Week 0 to Last Dose+4 weeks)

  4. 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.

    Time frame: Time Frame: Through study completion (Final Dose +24 weeks)

  5. Serum Concentrations

    To evaluate AZD0292 serum concentrations following IV dosing in participants with bronchiectasis and chronic colonization with PsA

    Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks

  6. 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

    Time frame: At specified timepoints between Week 0 and Final Dose +12 weeks

  7. 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

    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)

07

Study locations

40 of 40 sites recruiting
  • Research Site
    Anyang, 455099, China
    Recruiting
  • Research Site
    Beijing, 100020, China
    Recruiting
  • Research Site
    Beijing, 100034, China
    Recruiting
  • Research Site
    Beijing, 100730, China
    Recruiting
  • Research Site
    Changsha, 410005, China
    Recruiting
  • Research Site
    Chengdu, 610014, China
    Recruiting
  • Research Site
    Chengdu, 610078, China
    Recruiting
  • Research Site
    Chengdu, 611130, China
    Recruiting
  • Research Site
    Chizhou, 247099, China
    Recruiting
  • Research Site
    Haikou, 570311, China
    Recruiting
  • Research Site
    Hefei, 230061, China
    Recruiting
  • Research Site
    Hohhot, 010010, China
    Recruiting
  • Research Site
    Hohhot, 010050, China
    Recruiting
  • Research Site
    Jinan, 250013, China
    Recruiting
  • Research Site
    Jinhua, 321000, China
    Recruiting
  • Research Site
    Jining, 272006, China
    Recruiting
  • Research Site
    Kunming, 650032, China
    Recruiting
  • Research Site
    Langfang, 065000, China
    Recruiting
  • Research Site
    Linhai, 317000, China
    Recruiting
  • Research Site
    Liuzhou, 545006, China
    Recruiting
  • Research Site
    Nanchang, 330000, China
    Recruiting
  • Research Site
    Nanchang, 330006, China
    Recruiting
  • Research Site
    Nanning, 530021, China
    Recruiting
  • Research Site
    Shanghai, 200032, China
    Recruiting
  • Research Site
    Shanghai, 200065, China
    Recruiting
  • Research Site
    Shanghai, 200080, China
    Recruiting
  • Research Site
    Shanghai, 200240, China
    Recruiting
  • Research Site
    Shanghai, 201199, China
    Recruiting
  • Research Site
    Shenyang, 110004, China
    Recruiting
  • Research Site
    Taicang, 215400, China
    Recruiting
  • Research Site
    Taizhou, 318000, China
    Recruiting
  • Research Site
    Wenzhou, 325000, China
    Recruiting
  • Research Site
    Xinxiang, 453100, China
    Recruiting
  • Research Site
    Xuzhou, 221000, China
    Recruiting
  • Research Site
    Zaozhuang, 277102, China
    Recruiting
  • Research Site
    Zhangzhou, 363000, China
    Recruiting
  • Research Site
    Zhengzhou, 450000, China
    Recruiting
  • Research Site
    Zhengzhou, 450006, China
    Recruiting
  • Research Site
    Zhuzhou, 412007, China
    Recruiting
  • Research Site
    Zibo, 255036, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: 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.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jan 2028, 18 months after the start.

Of 24 phase 2 interventional studies under Bronchiectasis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 32. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2026
First posted
Aug 19, 2026
StartActual
Jun 24, 2026
Primary completionEst.
Jan 18, 2028
CompletionEst.
Jun 6, 2028
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
7 sites changed recruiting status (7 now recruiting)
Show 7 sites
  • Research Site · Beijing, ChinaNot yet recruiting→Recruiting
  • Research Site · Changsha, ChinaNot yet recruiting→Recruiting
  • Research Site · Hohhot, ChinaNot yet recruiting→Recruiting
  • Research Site · Jining, ChinaNot yet recruiting→Recruiting
  • Research Site · Shanghai, ChinaNot yet recruiting→Recruiting
  • Research Site · Shenyang, ChinaNot yet recruiting→Recruiting
  • Research Site · Zhengzhou, ChinaNot yet recruiting→Recruiting
Oct 8, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • EditedSerum PK ConcentrationsTime frame: At specified timepoints between Week 0 and Final Dose +12 weeks
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    7 sites changed recruiting status (7 now recruiting)
    Show 7 sites
    • Research Site · Beijing, ChinaNot yet recruiting→Recruiting
    • Research Site · Changsha, ChinaNot yet recruiting→Recruiting
    • Research Site · Hohhot, ChinaNot yet recruiting→Recruiting
    • Research Site · Jining, ChinaNot yet recruiting→Recruiting
    • Research Site · Shanghai, ChinaNot yet recruiting→Recruiting
    • Research Site · Shenyang, ChinaNot yet recruiting→Recruiting
    • Research Site · Zhengzhou, ChinaNot yet recruiting→Recruiting
    Secondary outcomes 1 edited
    What changed in the outcomes
    • EditedSerum PK ConcentrationsTime frame: At specified timepoints between Week 0 and Final Dose +12 weeks
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07774403
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Jun 24, 2026
Primary completion
Jan 18, 2028 (estimated)
Completion
Jun 6, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: AZD0292

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