What is involved if I take part?
The trial will compare the health of participants treated with Aztreonam with the health of participants given a placebo, a substance that looks the same as Aztreonam but is not an active medicine (dummy medicine). People who take part will not be able to choose whether they receive the Aztreonam medicine or the inactive medicine, this will be decided in a random way (a bit like tossing a coin but done by a computer). Neither you, your nurse nor you doctor will be told what you are prescribed. We will also compare the effects of two different doses of the medicines. Some people will take the medicine twice per day, while others will take it three times per day. This will be decided randomly.
Participation in the trial is entirely voluntary and you may withdraw at any time.
For the trial you will be asked to attend your local hospital six times over a 13-month period. Each visit will take approximately 2 hours.
At each visit you will be seen by a Researcher. During these visits the Researcher will do a simple health check, monitor your symptoms, and assess your lung function and oxygen level. You will have some blood samples and nose swabs taken and will be asked to produce a sputum sample. You will also be asked to complete three questionnaires about how you have been feeling.
You will be shown how to take your trial nebuliser and will then be asked to take it 2 or 3 times every day for a month when you will come back for a check up. The following month you will take no medicine, and the month after that you will take your medicine again. You will continue taking the nebuliser one month on, one month off for one year.
Will my taking part in the trial be kept confidential?
Yes. You can find out more about how we will use your information at http://www.ahspartnership.org.uk/tasc/for-the-public/how-we-use-your-information https://www.dundee.ac.uk/information-governance/dataprotection and at http://www.nhstayside.scot.nhs.uk/YourRights/PROD_298457/index.htmor or by contacting Research Govern-ance, Tayside Medical Science Centre (TASC), 01382 383900 email firstname.lastname@example.org