What is a research study?
A research study is a careful experiment to find out the answer to an important question about health.
Why is this research study being done?
We want to find a better way to treat children with serious asthma.
Where does the study take place?
The study visits take place in a hospital. At first, children are asked to come to hospital every month or two months for some tests. This is at the same time as their usual hospital visit, if possible.
They have to take about half a day off from school to come to the hospital for each visit.
If they are offered to take part in the second part of the study they are asked to come to hospital every month for the first 3 months to have the study medicine - this is at the same time as their usual hospital visit when possible. Every 4 months, they have some extra tests.
If possible, after the first 3 months we let them have the study medicine at home, but that is up to their doctor and parents/carer.
What happens to children taking part in this study?
The study has 2 parts:
In the beginning of the study the doctors do some blood tests and skin tests to find out more about the child's health and asthma. They give children a special monitor to go on their inhaler which tells the doctors more about how they use it.
The doctors then see them about 8-12 weeks after they have had the monitor on their inhaler, and check the results.
Then, if they think they need some extra medicine for their asthma they ask children if they want to take part in the second part of the study. If their asthma is better, or if they don’t want to take part any more, that’s fine.
For the first part of the study all children will do is have the monitor on their inhaler.
Who is taking part in this study?
We are inviting a total of 500 children (6 to 16 years old) from all over the country to take part in the first part of the study.
How long does the study take?
The first part of the study where inhaler use is monitored lasts for about 2-4 months. If children move onto the second part of the study where they start one of the injections (Omalizumab or Mepolizumab), the study lasts for 1 year.
Do children have to take part?
No, it is their choice.
What if a child said ‘Yes’ but then changed their mind?
Children are free to change their mind at any time during the trial.
Is there anything else that children in the trial might be worried about?
The tests and the medicines used in the study could have some side effects:
- Blood test: there may be a small bruise from the blood test
- Sputum test: children are asked to breath in some salty air for this test and it could make them cough
- Bronchoscopy: children are put to sleep for this test so they don't feel anything during the test. They may have some pain in their chest and a cough afterwards
- Medications: Omalizumab can cause pain in the arms and legs, make children feel dizzy or tired, give them a rash or cause pain in the ears. Mepolizumab may give children a headache, skin reactions where the injection went in, back pain and tiredness.
Will the study help children?
We hope medication can help children feel better. The study may not help every child, but the information we get might help treat other young people with problematic severe asthma better in the future.