A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
CLEAR
A 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
1 other identifier
interventional
435
25 countries
183
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 P75+ for phase_2
Started Nov 2025
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
November 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 14, 2028
May 7, 2026
May 1, 2026
2.1 years
July 17, 2025
May 6, 2026
Conditions
Keywords
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 Final Dose+4 weeks)
Change from baseline in SGRQ score
Over the observation period (Week 0 to Final Dose +4 weeks)
Time to first moderate or severe exacerbation
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 (3)
High-dose
EXPERIMENTALHigh-Dose AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Low-dose
EXPERIMENTALLow-dose AZD0292 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 ≥ 12 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
- Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months 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 (183)
Research Site
Orange, California, 92868, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Denver, Colorado, 80206, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Jacksonville, Florida, 32209, United States
Research Site
Miami Lakes, Florida, 33014, United States
Research Site
Naples, Florida, 34102, United States
Research Site
Ormond Beach, Florida, 32174, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Rincon, Georgia, 31326, United States
Research Site
Kansas City, Kansas, 66160, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
St Louis, Missouri, 63130, United States
Research Site
New York, New York, 10016, United States
Research Site
New Bern, North Carolina, 28562, United States
Research Site
Winston-Salem, North Carolina, 27104, United States
Research Site
Tulsa, Oklahoma, 74133, United States
Research Site
DuBois, Pennsylvania, 15801, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Rock Hill, South Carolina, 29732, United States
Research Site
Austin, Texas, 78705, United States
Research Site
Mansfield, Texas, 76063, United States
Research Site
Ciudad de Buenos Aires, C1180AAX, Argentina
Research Site
Florida, B1602DQD, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
San Miguel de Tucumán, 4000, Argentina
Research Site
Birtinya, 4575, Australia
Research Site
Macquarie University, 2109, Australia
Research Site
South Brisbane, 4101, Australia
Research Site
Ghent, 9000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4000, Belgium
Research Site
Sint-Niklaas, 9100, Belgium
Research Site
Blumenau, 89030-101, Brazil
Research Site
Campinas, 13060-080, Brazil
Research Site
Curitiba, 80030-110, Brazil
Research Site
Curitiba, 80230-130, Brazil
Research Site
Porto Alegre, 9061-000, Brazil
Research Site
Porto Alegre, 90630-165, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Salvador, 40050-410, Brazil
Research Site
São José dos Campos, 12230-001, Brazil
Research Site
São Paulo, 05.403-010, Brazil
Research Site
São Paulo, 05403-000, Brazil
Research Site
Calgary, Alberta, T2N4Z6, Canada
Research Site
Vancouver, British Columbia, V5Z 1M9, Canada
Research Site
Ajax, Ontario, L1S 2J5, Canada
Research Site
Stoney Creek, Ontario, L8G 2V6, Canada
Research Site
Québec, Quebec, G1V 4G5, Canada
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Research Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Research Site
Concepción, 4070196, Chile
Research Site
Santiago, 8150000, Chile
Research Site
Santiago, 8380453, Chile
Research Site
Talca, 3481349, Chile
Research Site
Viña del Mar, 2540364, Chile
Research Site
Aalborg, 9000, Denmark
Research Site
Aarhus N, 8200, Denmark
Research Site
Hvidovre, 2650, Denmark
Research Site
Odense C, 5000, Denmark
Research Site
Roskilde, 4000, Denmark
Research Site
Brest, 29200, France
Research Site
Créteil, 94010, France
Research Site
Marseille, 13915, France
Research Site
Montpellier, 34295, France
Research Site
Paris, 75014, France
Research Site
Pessac, 33604, France
Research Site
Strasbourg, 67091, France
Research Site
Toulouse, 31100, France
Research Site
Darmstadt, 64283, Germany
Research Site
Essen, 45239, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Halle, 06108, Germany
Research Site
Hanover, 30625, Germany
Research Site
Konstanz, 78464, Germany
Research Site
München, 80336, Germany
Research Site
München-Pasing, 81241, Germany
Research Site
Athens, 11527, Greece
Research Site
Athens, 12462, Greece
Research Site
Athens, 15126, Greece
Research Site
Athens, 17562, Greece
Research Site
Ioannina, 45500, Greece
Research Site
Larissa, 41110, Greece
Research Site
Pátrai, 26500, Greece
Research Site
Thessaloniki, 57010, Greece
Research Site
Ashkelon, 7830604, Israel
Research Site
Haifa, 34362, Israel
Research Site
Jerusalem, 00000, Israel
Research Site
Jerusalem, 91031, Israel
Research Site
Ramat Gan, 52621, Israel
Research Site
Tel Aviv, 6423906, Israel
Research Site
Milan, 20122, Italy
Research Site
Palermo, 90127, Italy
Research Site
Pavia, 27100, Italy
Research Site
Perugia, 06129, Italy
Research Site
Roma, 00163, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Torrette, 60126, Italy
Research Site
Bunkyō City, 113-8655, Japan
Research Site
Gifu, 500-8717, Japan
Research Site
Hiratsuka-shi, 254-8502, Japan
Research Site
Kamogawa-shi, 296-0041, Japan
Research Site
Kiyose-shi, 204-8522, Japan
Research Site
Kiyose-shi, 204-8585, Japan
Research Site
Kurashiki-shi, 710-8602, Japan
Research Site
Miyazaki, 889-1692, Japan
Research Site
Nagasaki, 852-8501, Japan
Research Site
Ogi, 845-0032, Japan
Research Site
Shinjuku-ku, 160-8582, Japan
Research Site
Shinjuku-ku, 162-8655, Japan
Research Site
Urayasu-shi, 279-0021, Japan
Research Site
Bandar Puncak Alam, 42300, Malaysia
Research Site
Kuala Lumpur, 59100, Malaysia
Research Site
Sibu, 96000, Malaysia
Research Site
Amsterdam, 1081 HV, Netherlands
Research Site
Rotterdam, 3015 GD, Netherlands
Research Site
Zutphens, 7207 AE, Netherlands
Research Site
Bellavista, CALLAO 2, Peru
Research Site
Callao, Bellavista, Peru
Research Site
Lima, 15023, Peru
Research Site
Lima, 15036, Peru
Research Site
Lima, 15038, Peru
Research Site
Lima, 15082, Peru
Research Site
Lima, 15088, Peru
Research Site
Lima, LIMA 1, Peru
Research Site
Lima, LIMA 29, Peru
Research Site
Iloilo City, 5000, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Quezon City, 1100, Philippines
Research Site
Tondo, 1012, Philippines
Research Site
Anyang-si, 14068, South Korea
Research Site
Cheongju-si, 28644, South Korea
Research Site
Daegu, 42415, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 04763, South Korea
Research Site
Seoul, 05030, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 07441, South Korea
Research Site
Ulsan, 44033, South Korea
Research Site
Barcelona, 08003, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Benalmádena, 29631, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28046, Spain
Research Site
Mérida, 06800, Spain
Research Site
Patraix, 46017, Spain
Research Site
Valencia, 46009, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 0116, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Bang Kra So, 11000, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Khon Kaen, 40002, Thailand
Research Site
Muang, 50200, Thailand
Research Site
Pathum Thani, 12120, Thailand
Research Site
Adana, 1330, Turkey (Türkiye)
Research Site
Ankara, 6340, Turkey (Türkiye)
Research Site
Diyarbakır, 21280, Turkey (Türkiye)
Research Site
Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34890, Turkey (Türkiye)
Research Site
Mersin, 33343, Turkey (Türkiye)
Research Site
Zeytinburnu, 34020, Turkey (Türkiye)
Research Site
Belfast, BT9 7AB, United Kingdom
Research Site
Birmingham, B9 5SS, United Kingdom
Research Site
Brighton, BN2 1ES, United Kingdom
Research Site
Cambridge, CB2 0AY, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
Edinburgh, EH16 4SA, United Kingdom
Research Site
Exeter, EX2 5DW, United Kingdom
Research Site
Liverpool, L14 3PE, United Kingdom
Research Site
Manchester, M23 9LT, United Kingdom
Research Site
Can Tho, 900000, Vietnam
Research Site
Haiphong, 180000, Vietnam
Research Site
Hanoi, 100000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Huế, 530000, Vietnam
Related Publications (40)
Araujo D, Shteinberg M, Aliberti S, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Stone G, Trautmann M, Davis A, Dimakou K, Polverino E, De Soyza A, McDonnell MJ, Chalmers JD. The independent contribution of Pseudomonas aeruginosa infection to long-term clinical outcomes in bronchiectasis. Eur Respir J. 2018 Jan 31;51(2):1701953. doi: 10.1183/13993003.01953-2017. Print 2018 Feb.
PMID: 29386336BACKGROUNDArtaraz A, Crichton ML, Finch S, Abo-Leyah H, Goeminne P, Aliberti S, Fardon T, Chalmers JD. Development and initial validation of the bronchiectasis exacerbation and symptom tool (BEST). Respir Res. 2020 Jan 13;21(1):18. doi: 10.1186/s12931-019-1272-y.
PMID: 31931782BACKGROUNDBellelli G, Chalmers JD, Sotgiu G, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Skrbic D, Lombi A, Pane F, Obradovic D, Fardon TC, Rutherford RM, Pesci A, Aliberti S. Characterization of bronchiectasis in the elderly. Respir Med. 2016 Oct;119:13-19. doi: 10.1016/j.rmed.2016.08.008. Epub 2016 Aug 17.
PMID: 27692133BACKGROUNDCFFPR 2023 Cystic Fibrosis Foundation Patient Registry. Bethesda, MD. 2023 Annual Data Report. Available at https://www.cff.org/media/34491/download.
BACKGROUNDChalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
PMID: 24328736BACKGROUNDChalmers JD, Aliberti S, Blasi F. Management of bronchiectasis in adults. Eur Respir J. 2015 May;45(5):1446-62. doi: 10.1183/09031936.00119114. Epub 2015 Mar 18.
PMID: 25792635BACKGROUNDChalmers JD, Chang AB, Chotirmall SH, Dhar R, McShane PJ. Bronchiectasis. Nat Rev Dis Primers. 2018 Nov 15;4(1):45. doi: 10.1038/s41572-018-0042-3.
PMID: 30442957BACKGROUNDChalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
PMID: 29357265BACKGROUNDChalmers JD, Chotirmall SH. Bronchiectasis: new therapies and new perspectives. Lancet Respir Med. 2018 Sep;6(9):715-726. doi: 10.1016/S2213-2600(18)30053-5. Epub 2018 Feb 23.
PMID: 29478908BACKGROUNDChawla K, Vishwanath S, Manu MK, Lazer B. Influence of pseudomonas aeruginosa on exacerbation in patients with bronchiectasis. J Glob Infect Dis. 2015 Jan-Mar;7(1):18-22. doi: 10.4103/0974-777X.150885.
PMID: 25722615BACKGROUNDChoate R, Aksamit TR, Mannino D, Addrizzo-Harris D, Barker A, Basavaraj A, Daley CL, Daniels MLA, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, McShane PJ, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL, Stone G. Pseudomonas aeruginosa associated with severity of non-cystic fibrosis bronchiectasis measured by the modified bronchiectasis severity score (BSI) and the FACED: The US bronchiectasis and NTM Research Registry (BRR) study. Respir Med. 2021 Feb;177:106285. doi: 10.1016/j.rmed.2020.106285. Epub 2020 Dec 24.
PMID: 33401148BACKGROUNDChoi H, Xu JF, Chotirmall SH, Chalmers JD, Morgan LC, Dhar R. Bronchiectasis in Asia: a review of current status and challenges. Eur Respir Rev. 2024 Sep 25;33(173):240096. doi: 10.1183/16000617.0096-2024. Print 2024 Jul.
PMID: 39322263BACKGROUNDCiofu O, Tolker-Nielsen T. Tolerance and Resistance of Pseudomonas aeruginosa Biofilms to Antimicrobial Agents-How P. aeruginosa Can Escape Antibiotics. Front Microbiol. 2019 May 3;10:913. doi: 10.3389/fmicb.2019.00913. eCollection 2019.
PMID: 31130925BACKGROUNDDiGiandomenico A, Warrener P, Hamilton M, Guillard S, Ravn P, Minter R, Camara MM, Venkatraman V, Macgill RS, Lin J, Wang Q, Keller AE, Bonnell JC, Tomich M, Jermutus L, McCarthy MP, Melnick DA, Suzich JA, Stover CK. Identification of broadly protective human antibodies to Pseudomonas aeruginosa exopolysaccharide Psl by phenotypic screening. J Exp Med. 2012 Jul 2;209(7):1273-87. doi: 10.1084/jem.20120033. Epub 2012 Jun 25.
PMID: 22734046BACKGROUNDEmerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatr Pulmonol. 2002 Aug;34(2):91-100. doi: 10.1002/ppul.10127.
PMID: 12112774BACKGROUNDFLETCHER CM, ELMES PC, FAIRBAIRN AS, WOOD CH. The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J. 1959 Aug 29;2(5147):257-66. doi: 10.1136/bmj.2.5147.257. No abstract available.
PMID: 13823475BACKGROUNDGraham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PMID: 31613151BACKGROUNDGuo J, Garratt A, Hill A. Worldwide rates of diagnosis and effective treatment for cystic fibrosis. J Cyst Fibros. 2022 May;21(3):456-462. doi: 10.1016/j.jcf.2022.01.009. Epub 2022 Feb 4.
PMID: 35125294BACKGROUNDHarrington NE, Kottara A, Cagney K, Shepherd MJ, Grimsey EM, Fu T, Hull RC, Chong CE, Baker KS, Childs DZ, Fothergill JL, Chalmers JD, Brockhurst MA, Paterson S. Global genomic diversity of Pseudomonas aeruginosa in bronchiectasis. J Infect. 2024 Nov;89(5):106275. doi: 10.1016/j.jinf.2024.106275. Epub 2024 Sep 16.
PMID: 39293722BACKGROUNDHill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
PMID: 28596426BACKGROUNDHorcajada JP, Montero M, Oliver A, Sorli L, Luque S, Gomez-Zorrilla S, Benito N, Grau S. Epidemiology and Treatment of Multidrug-Resistant and Extensively Drug-Resistant Pseudomonas aeruginosa Infections. Clin Microbiol Rev. 2019 Aug 28;32(4):e00031-19. doi: 10.1128/CMR.00031-19. Print 2019 Sep 18.
PMID: 31462403BACKGROUNDJones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
PMID: 1759018BACKGROUNDJones 2022 Jones P. St George's Respiratory Questionnaire Manual. Version 2.4. St George's University of London. March 2022. Available at https://www.sgul.ac.uk/research/researchoperations/ research-administration/st-georges-respiratory-questionnaire/docs/SGRQ-Manual- March-2022.pdf.
BACKGROUNDLaska IF, Crichton ML, Shoemark A, Chalmers JD. The efficacy and safety of inhaled antibiotics for the treatment of bronchiectasis in adults: a systematic review and meta-analysis. Lancet Respir Med. 2019 Oct;7(10):855-869. doi: 10.1016/S2213-2600(19)30185-7. Epub 2019 Aug 9.
PMID: 31405826BACKGROUNDLong MB, Gilmour A, Kehl M, Tabor DE, Keller AE, Warrener P, Gopalakrishnan V, Rosengren S, Crichton ML, McIntosh E, Giam YH, Keir HR, Brailsford W, Hughes R, Belvisi MG, Sellman BR, DiGiandomenico A, Chalmers JD. A Bispecific Monoclonal Antibody Targeting Psl and PcrV Enhances Neutrophil-Mediated Killing of Pseudomonas aeruginosa in Patients with Bronchiectasis. Am J Respir Crit Care Med. 2024 Jul 1;210(1):35-46. doi: 10.1164/rccm.202308-1403OC.
PMID: 38754132BACKGROUNDLong et al 2025 Long MB, Hull RC, Gilmour A, Viligorska K, Richardson H, New BJM, et al. A bispecific monoclonal antibody targeting Psl and PcrV for chronic pseudomonas aeruginosa infection in patients With bronchiectasis: results From a randomized, double-blind placebo-controlled trial (GREAT-2) [abstract]. Am J Respir Crit Care Med 2025;211:A3117.
BACKGROUNDNigro M, Laska IF, Traversi L, Simonetta E, Polverino E. Epidemiology of bronchiectasis. Eur Respir Rev. 2024 Oct 9;33(174):240091. doi: 10.1183/16000617.0091-2024. Print 2024 Oct.
PMID: 39384303BACKGROUNDO'Donnell AE. Bronchiectasis - A Clinical Review. N Engl J Med. 2022 Aug 11;387(6):533-545. doi: 10.1056/NEJMra2202819. No abstract available.
PMID: 35947710BACKGROUNDOswalt ML, Kemp SF. Anaphylaxis: office management and prevention. Immunol Allergy Clin North Am. 2007 May;27(2):177-91, vi. doi: 10.1016/j.iac.2007.03.004.
PMID: 17493497BACKGROUNDQuanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
PMID: 22743675BACKGROUNDQuittner AL, Marciel KK, Salathe MA, O'Donnell AE, Gotfried MH, Ilowite JS, Metersky ML, Flume PA, Lewis SA, McKevitt M, Montgomery AB, O'Riordan TG, Barker AF. A preliminary quality of life questionnaire-bronchiectasis: a patient-reported outcome measure for bronchiectasis. Chest. 2014 Aug;146(2):437-448. doi: 10.1378/chest.13-1891.
PMID: 24626872BACKGROUNDQuittner AL, O'Donnell AE, Salathe MA, Lewis SA, Li X, Montgomery AB, O'Riordan TG, Barker AF. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015 Jan;70(1):12-20. doi: 10.1136/thoraxjnl-2014-205918. Epub 2014 Oct 16.
PMID: 25323621BACKGROUNDSampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006 Feb;117(2):391-7. doi: 10.1016/j.jaci.2005.12.1303.
PMID: 16461139BACKGROUNDSibila O, Laserna E, Shoemark A, Keir HR, Finch S, Rodrigo-Troyano A, Perea L, Lonergan M, Goeminne PC, Chalmers JD. Airway Bacterial Load and Inhaled Antibiotic Response in Bronchiectasis. Am J Respir Crit Care Med. 2019 Jul 1;200(1):33-41. doi: 10.1164/rccm.201809-1651OC.
PMID: 31109172BACKGROUNDSong J, Sin S, Kang HR, Oh YM, Jeong I; KMBARC. Clinical Impacts of Pseudomonas aeruginosa Isolation in Patients with Bronchiectasis: Findings from KMBARC Registry. J Clin Med. 2024 Aug 24;13(17):5011. doi: 10.3390/jcm13175011.
PMID: 39274224BACKGROUNDTabor DE, Oganesyan V, Keller AE, Yu L, McLaughlin RE, Song E, Warrener P, Rosenthal K, Esser M, Qi Y, Ruzin A, Stover CK, DiGiandomenico A. Pseudomonas aeruginosa PcrV and Psl, the Molecular Targets of Bispecific Antibody MEDI3902, Are Conserved Among Diverse Global Clinical Isolates. J Infect Dis. 2018 Nov 5;218(12):1983-1994. doi: 10.1093/infdis/jiy438.
PMID: 30016475BACKGROUNDTomaszewski EL, Atkinson MJ, Janson C, Karlsson N, Make B, Price D, Reddel HK, Vogelmeier CF, Mullerova H, Jones PW; NOVELTY Scientific Community; NOVELTY study investigators. Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD. Respir Res. 2023 Apr 8;24(1):106. doi: 10.1186/s12931-023-02394-6.
PMID: 37031164BACKGROUNDWHO 2017 WHO. WHO/EMP/IAU/2017.12 Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis. Report. World Health Organization, WHO, Antimicrobial Resistance Division Global Coordination and Partnership, Medicines Selection, IP and Affordability. Available from: http://www.who.int/publications/i/item/WHO-EMP-IAU-2017.02.
BACKGROUNDWilson R, Aksamit T, Aliberti S, De Soyza A, Elborn JS, Goeminne P, Hill AT, Menendez R, Polverino E. Challenges in managing Pseudomonas aeruginosa in non-cystic fibrosis bronchiectasis. Respir Med. 2016 Aug;117:179-89. doi: 10.1016/j.rmed.2016.06.007. Epub 2016 Jun 7.
PMID: 27492530BACKGROUNDZolin et al 2024 Zolin A, Adamoli A, Bakkeheim E, van Rens J, et al. ECFSPR Annual Report 2022. Published 2024. Available at https://www.ecfs.eu/sites/default/files/Annual%20Report_2022_ECFSPR_20240603.pdf.
BACKGROUND
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
- Masking Details
- Participants, Investigators, site staff, and AstraZeneca study staff who are involved in the treatment or clinical evaluation and monitoring of the participants will remain blinded to each participant's treatment assignment throughout the course of the study. As AZD0292 and placebo are visually distinct prior to dose preparation, an unblinded pharmacist (or designee, in accordance with local and institutional regulations) will be responsible for the handling and dose preparation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2025
First Posted
July 28, 2025
Study Start
November 6, 2025
Primary Completion (Estimated)
December 9, 2027
Study Completion (Estimated)
June 14, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
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.