What does it mean that TREAT is a ‘randomised’ study?
In this study, we use a standardised approach for all children and then give them either omalizumab or mepolizumab to see which, if any of those medicines is better, and which works best in which patient. To find out which is better, children are put into two equal groups and each group is given one of the two treatments. To try to make sure the groups are the same to start with, each participant is put into a group by chance (randomly). This is done so that each child has the same chance of receiving either treatment, and assignment to the treatment is determined using a specially designed computer system to ensure that there is a 50/50 chance of joining either group.
This study is ‘open-label’ which means both the patients (and their parents) and the study doctors will know which treatment is being given.
How many children will take part in TREAT?
This will be the largest study of severe asthma in children in the UK.
The first part of this study, which involves monitoring how children take their inhalers for a minimum of 8 weeks, and up to 16 weeks, will include 500 children with severe problematic asthma.
The second part of the study will include 150 children across hospitals in the UK. The second part of the study will take a year - during this time children will receive one of the two treatments being compared.
How is the treatment administered?
Patients are randomly assigned to one of the two treatments. Omalizumab or mepolizumab is administered every 2 to 4 weeks for 52 weeks. The initial injections are given in hospital, but after the first 3, if the child and caregiver and their consultant agree, patients can be shown how to give the injection and it can be done at home.
What happens to children taking part in the TREAT trial?
When a patient and their parent/caregiver agree to take part in this study, they need to have regular study visits. The study is carried out in two main parts; the first part of the study involves a period of adherence monitoring using an electronic monitor attached to their usual inhaler, and this lasts for at least 2 months. If after the initial monitoring, asthma control improves, then the patient will not continue into the next phase of the study. However, if asthma continues to be difficult to control and troublesome despite good adherence, then the patient will have the study medication. The second part of the study is where the patient receives the trial medication (injections), and this happens for 1 year.
Are you interested in your child taking part in the TREAT trial?
Please ask your GP or local hospital to refer you to the most appropriate site. See ‘About’ –‘The TREAT Trial’ for a list and map of participating sites.