• Principal Investigator/s:

Dr Steven Caskey

• Name of the Study:

GREAT-2 – GRemubamab ErAdication Trial.  Gremubamab compared to placebo in participants with bronchiectasis and chronic Pseudomonas aeruginosa infection

• Why is this Study important?

Patients with bronchiectasis frequently get chest infections which are difficult to treat and can cause coughing, sputum (phlegm) production, breathlessness and tiredness.  Approximately one third of people with bronchiectasis become infected with a bacteria called Pseudomonas aeruginosa (P. aeruginosa). P. aeruginosa often becomes resistant to antibiotics which means antibiotics don’t work. People are often left with a chronic infection which is difficult to treat. Having a chronic infection with P. aeruginosa may lead to a greater likelihood of hospital admission, and may also increase the risk of more serious illness.

• What is the Research question/aim?

The purpose of this trial is to test whether an intravenous infusion (drip) containing a new drug called Gremubamab can reduce the amount of infection with P. aeruginosa. We will also assess whether people with bronchiectasis can take this drug safely and whether it reduces the number of bronchiectasis exacerbations and improves quality of life.

• What the Study involves:

There are a number of non-clinical and clinical interventions including blood sampling, sputum sampling, ECG, spirometry and study questionnaires.

Patients will be in the trial for approximately 6 months which will involve attending hospital for 8 appointments and having 3 Gremubamab or placebo infusions during that time. If there is an exacerbation of bronchiectasis during the trial, patients will attend for an extra visit to assess their symptoms. This does not mean that they would necessarily have to stop the trial treatment.

• Who can take part in the Study?

Patients who have bronchiectasis and have had an infection caused by P. aeruginosa in the last 2 years or who provide a sputum sample that is culture or PCR positive for P. aeruginosa.  The investigator and sub-investigators will check that the potential patients meet the main eligibility criteria by studying their medical history as documented in their medical notes and assessing their current disease status with a physical examination.

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