Overview of this trial
GREAT-2 is a clinical trial to test a new treatment for bronchiectasis.
People with bronchiectasis frequently get chest infections which are difficult to treat. Approximately one third of people with bronchiectasis become infected with a bacteria called Pseudomonas aeruginosa (P. aeruginosa). People are often left with a chronic infection which is difficult to treat. Having a chronic infection with P. aeruginosa may lead to more hospital admissions and may increase the risk of more serious illness.
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. We will also look to see if Gremubamab reduces the number of bronchiectasis exacerbations and improves quality of life.
Gremubamab is a type of drug called a monoclonal antibody which we hope will work with the immune system to eliminate the P. aeruginosa bacterial infection.
How will Gremubamab be tested?
We will compare the health of participants treated with Gremubamab with the health of participants given a placebo. A placebo is a substance that looks the same as Gremubamab but is not an active medicine.
The participant will not be able to choose whether they receive the Gremubamab medicine or the placebo medicine, this will be decided in a random way (a bit like tossing a coin but done by a computer). The patient, research nurse and doctor will not know whether the participant is given Gremubamab or placebo. This is called a blinded trial.
We will also compare the effects of two different doses of the medicines. Half the participants will be given a higher dose than the rest. This will be decided randomly and neither the patient, research nurse nor doctor will be told what dose the patient is prescribed until after the trial is complete.
What does participating in the trial involve?
If you are interested in taking part, you will be asked to attend an initial screening visit, to assess if you are eligible to take part in the trial. At this screening visit you will be asked to sign an informed consent form before any trial assessments take place.
If you agree to take part, a nurse will give you a physical examination and take measurements (including blood pressure, height & weight, ECG, spirometry) and samples (including blood & sputum). The nurse will also ask questions about your general health and medications you are taking. If you are found to be eligible for the study you will be invited to the other trial visits. At visit 2 you will be randomised to receive either Gremubamab or placebo treatment and you will receive the first dose of trial medication.
Further steps involved in the trial are shown in the table below, including what assessments will happen at each trial visit.
| Visit 1 | Visit 2 (1st dose) | Visit 3 | Visit 4 | Visit 5 (2nd dose) | Visit 6 (3rd dose) | Visit 7 | Phone call | Visit 8 | Extra Visits | |
| Screening | Start | Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | if required | |
| Consent form | X | |||||||||
| Health & medication check | X | X | X | X | X | X | X | X | X | X |
| Physical examination | X | X | ||||||||
| ECG | X | |||||||||
| Blood pressure, pulse, temperature and oxygen saturation | X | X | X | X | X | X | X | X | X | |
| Pregnancy test (if applicable) | X | X | X | X | X | |||||
| Blood samples | X | X | X | X | X | X | X | X | X | |
| Sputum samples | X | X | X | X | X | X | X | X | X | |
| Spirometry | X | X | X | X | X | |||||
| Questionnaires | X | X | X | X | X | X | X | X | ||
| Antihistamine | X | X | X | |||||||
| Trial medication | X | X | X |
You may also be asked to attend additional visits if required for your health.
How can you take part?
The trial is taking place in hospitals across the UK & Spain. People who have bronchiectasis and who have had a P. aeruginosa infection in the last 2 years may be eligible to take part in this trial. The study team will assess patients at the first screening visit, to ensure you are eligible for this trial. A total of 90 participants will take part in the trial.
Details of hospitals taking part in the GREAT-2 trial are on the Get Involved page
By taking part you are contributing to medical science and the results may help other people in the future.
Can I withdraw from the trial if I change my mind?
Yes, you can withdraw at any time. You do not need to give us a reason, but it will help with our research if you could let us know why you no longer want to take part in the trial.
Will my taking part in the trial be kept confidential?
Yes. You can find out more about how we will use your information at How we use your information
Data Protection – University of Dundee and Data Protection NHS Tayside
The trial is being Sponsored by the University of Dundee & NHS Tayside and is being managed by Tayside Clinical Trials Unit.
