Frequently asked questions
How long will the PROMIS Study take?
The PROMIS Study will last for up to 58 weeks (just over 13 months) for each participant. This includes:
- A 1 month Screening period
- A 12 month Treatment period
- A 2-week Follow-up period.
How many visits will the patient need to attend?
The participant will be required to attend 7 visits to the Study Center in total:
- One visit for Screening
- 5 visits during the Treatment period
- One visit at the End of Study.
- In addition, one follow-up phone call
What treatment will the patient be given?
If the patient (participant) is eligible and chooses to take part in this study, the participant will be allocated to one of two treatment groups:
- The antibiotic being studied
- Dummy (placebo) treatment
The participant has an equal chance of being in any of these two treatment groups. The treatment allocation is “blinded”. This means that the doctor and other Study Center staff will not know which treatment the participant is receiving and neither will the participant. This is very important to assess if the drug really works.
What procedures and assessments are involved?
At each visit, the participant will need to have different assessments and procedures performed, ranging from filling out forms and answering questionnaires about how the participant feels, to having blood and urine samples taken. These will change at the different visits. The participant will also have various physical measurements taken, such as height, weight and blood pressure, as well as an electrocardiogram (ECG), which measures the electrical activity of the heart and lung function test to see how well the participant’s lungs work.
What safety measures are in place?
Participant’s health will be monitored throughout the PROMIS Study and at each study visit the participant will be asked to report any side effects he/she has experienced.
In the case of an emergency, there is a procedure in place to find out what treatment the participant is on so that he/she can receive the correct care.
What if the participant is unable to attend a visit?
The participant needs to contact the Study Center staff as soon as possible to try and rearrange the visit. It is important to attend all visits so we ask that the participant is committed to attending the agreed visit times as much as possible.
Will it cost him anything to participate in the PROMIS Study?
The participant does not have to pay for the study medication, study visits or any tests that are part of the study. The participant may be reimbursed for necessary expenses (e.g. the cost of the transport to and from visits).
What happens if I am unwell?
The participant will be treated as normal for any illnesses or exacerbations the participant may have while taking part in the study. We ask that all exacerbations are reported to the Study Center and they may ask the participant to visit, if able.