A study to evaluate the safety and effectiveness of AZD0292 in people aged 12 years and older with bronchiectasis and chronic Pseudomonas aeruginosa infection

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What is this study about?

This study focuses on individuals living with Bronchiectasis, a condition where the airways in the lungs become permanently widened and damaged, making it difficult to clear mucus. This condition is often complicated by Pseudomonas aeruginosa colonization, which occurs when a specific type of bacteria lives in the airways for a long time. The purpose of the study is to evaluate the effectiveness and safety of a medication called AZD0292. This treatment is provided as a solution for infusion, which means it is delivered directly into the bloodstream through a needle or tube.

During the trial, participants are assigned to receive either AZD0292 or a placebo. The study is double-blind, meaning that neither the participants nor the researchers know which treatment is being administered until the study is finished. The research will monitor how the medication moves through the body, a process known as pharmacokinetics, and track any pulmonary exacerbations, which are sudden increases in symptoms like coughing or shortness of breath. Participants will be monitored over a period of time to observe how the treatment affects the frequency of these lung symptom flare-ups.

Who Can Join the Study?

  • You must be at least 18 years old when you sign the study agreement.
  • Your weight must be 35 kilograms (about 77 pounds) or more.
  • A doctor must have diagnosed you with bronchiectasis, which is a condition where the airways in your lungs become widened and damaged. This must be confirmed by a CT scan (a special type of X-ray image) showing abnormal widening in at least one part of the lung.
  • You must be receiving the standard of care, which means the usual medical treatments recommended by doctors for your condition.
  • You must have a history of at least two moderate flare-ups (sudden worsening of symptoms) or one severe flare-up in the last 12 months that required antibiotics (medicine used to fight bacterial infections).
  • You must be clinically stable, meaning your condition is steady and you have not had a lung flare-up for at least 4 weeks before being assigned to a study group.
  • Your FEV1, which is a test that measures how much air you can forcefully exhale in one second, must be at least 25% of the expected value for someone of your age and size.
  • You must have tested positive for Pseudomonas aeruginosa (PsA), a type of bacteria, in your airways through a culture (growing bacteria in a lab) or PCR test (a test that looks for the bacteria’s genetic material) at least once in the last 24 months.
  • You must have a positive test for the PsA bacteria in your sputum (the thick mucus you cough up from your lungs) within 5 weeks before starting the study.
  • Even if you have previously tried treatments to get rid of the PsA bacteria, you can still join if the bacteria are still present in your system.
  • You must be able to understand and sign an informed consent form, which is a document that explains all the details, rules, and risks of the study.

Who Cannot Join the Study?

  • Having a main lung condition that is not bronchiectasis, which is a long-term disease where the airways in the lungs become widened and damaged.
  • Using any experimental medicines intended to treat or prevent lung flare-ups, or planning to use them during the study.
  • People with Cystic Fibrosis (a genetic disorder affecting the lungs and digestive system) who started CFTR modulator therapies, which are drugs that help improve how certain proteins work in the body, within the last 3 months.
  • Female participants who are pregnant, breastfeeding, or could become pregnant and are not using a very reliable form of contraception (birth control) or practicing abstinence.
  • Having tuberculosis (a serious infection caused by bacteria) or nontuberculous mycobacteria (a group of bacteria that can cause lung infections) that is currently being treated or needs treatment.
  • Having allergic bronchopulmonary aspergillosis, which is an allergic reaction to a specific type of fungus in the lungs, that is currently being treated or needs treatment.
  • Needing to use supplemental oxygen for long periods, though using oxygen for walking or to help with shortness of breath after exercise is allowed.
  • Having malignancy, which is another word for cancer, that is current or occurred within the last 5 years. This does not include stable prostate cancer, certain skin cancers, or specific types of cervical cancer that were successfully treated.
  • Having AIDS or advanced human immunodeficiency virus (HIV) disease, specifically a CD4 count (a measure of immune system cells) of less than 200 cells/mm3.
  • A history of severe allergic reactions to monoclonal antibodies, which are laboratory-made proteins used to treat diseases, including anaphylaxis (a life-threatening allergic reaction) or immune complex disease (a condition where the immune system attacks the body’s own tissues).
  • Starting long-term antibiotics used to treat PsA (a specific type of bacteria), macrolides (a type of antibiotic), or DPP-1 inhibitors (a type of medicine) within the last 3 months.
  • Starting long-term immunosuppressive therapy, which are medicines that lower the body’s ability to fight infection, such as prednisolone, within the last 3 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital Del Mar Barcelona Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Azienda Ospedaliera Di Perugia Perugia Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Vitaz Sint-Niklaas Belgium
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Hospital De Merida Merida Spain
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Lungenheilkunde München-Pasing Munich Germany
Odense University Hospital Odense Denmark
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Ioannina Ioannina Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Irccs San Raffaele Roma S.r.l. Rome Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Aalborg University Hospital Aalborg Denmark
General University Hospital Of Patras Patras Greece
Hospital Vithas Xanit Internacional Benalmadena Spain
Klinikum Konstanz GmbH Konstanz Germany
Gelre Hospitals Zutphen The Netherlands
Hopital Beaujon Clichy France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Region Sjaelland Holbæk Denmark
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Sfyayipbogce Gigtvou Hztcwtis Athens Greece
Lvndn Gqkvsaa Hgvoeviy Ov Aszwgb Athens Greece
Hdemve Hwppvxim Herlev Denmark
Attvajebh Uck Amsterdam The Netherlands
Agfodrxpnu Piuoqbfi Hsoskqkt Db Mkvhvsksb Marseille France
Eqafbaa Uouftfwilsvg Mgdnhtp Cvzmmpy Rqqlpinkv (jlfscqt Mcg Rotterdam The Netherlands
Asllfk Mkmkijk Czfmsk Svms Thessaloniki Greece
Kglljbte dlv Uuekrslcvkeq Mctfxtyq Azk Munich Germany
Fnaujizcj Pqan Ld Irjwqwxgruhsw Bxfjrimqr Dsr Hwirtxzc Uiqyqktodenit Lp Pim Madrid Spain
Pebyiaalncmrb Hsfjy Halle (Saale) Germany
Hyuspuou Uecgabpfgflgns Simgpmyxkp &dkhyhs Hryxgbv dp Hndqqvlsanw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
12.11.2025
Denmark Denmark
Recruiting
12.11.2025
France France
Recruiting
12.11.2025
Germany Germany
Recruiting
12.11.2025
Greece Greece
Recruiting
12.11.2025
Italy Italy
Recruiting
12.11.2025
Spain Spain
Recruiting
12.11.2025
The Netherlands The Netherlands
Recruiting
12.11.2025

Trial locations

Investigated drugs:

AZD0292 is an experimental medicine given through an IV drip to help treat people with bronchiectasis and a long-term infection of a specific bacteria called Pseudomonas aeruginosa. This study is testing how well this medicine works to reduce the frequency of serious lung flare-ups.

Investigated diseases:

Bronchiectasis with chronic pseudomonas aeruginosa colonization – This condition occurs when the airways in the lungs become permanently widened and damaged. This damage makes it difficult for the lungs to clear mucus, which can lead to frequent infections. In this specific case, a certain type of bacteria called pseudomonas aeruginosa stays in the airways over a long period. The presence of this bacteria can cause repeated flare-ups of lung symptoms. As the condition progresses, the buildup of mucus and bacteria can lead to increasing inflammation in the respiratory tract.

Trial ID:
2025-523009-14-00
Protocol code:
D7700C00003
Trial Phase:
Therapeutic exploratory (Phase II)

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