Management of Asthma in School-age Children on Therapy
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative
medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment
Guidelines recommend when this treatment is not working other treatments are started. Studies
to support this have taken place in adults but not with children. If patients are instructed
how to use inhalers and are given information about asthma, they can control their disease
much better. The first part of this study, lasting 4 weeks, will make sure the children and
their families understand how to use their inhaler. All children will be given the same
steroid inhaler to use and after 4 weeks those still with symptoms will enter the study
proper which lasts for 48 weeks. During this part of the study the children will be given one
of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler containing a
steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an active tablet.
In this way the patient, the family and the researchers will not know which of the three
treatments the child is taking until the code is broken at the end of the study.
What matters to children is how they feel, are they able to run around and play with friends
and are they well enough to go to school. The investigators will assess which of the above
treatments best allow these to happen by asking the parents and children to fill in
questionnaires on 4 occasions during the study. The investigators will also see which
treatment best prevents the need for short courses of steroids tablets during the study.
These are commonly given when asthma symptoms worsen.
Most children will be started in the study through their general practitioner clinic. It will
take one year to enroll all 900 children. Once enrolled the children will be followed-up in
hospital centres. Much of the funding will be required to recruit and follow-up the children,
train everyone to the same standard and develop and administer the questionnaires and health
economic assessments. Asthma care is an expensive. The investigators will look at the costs
and assess which treatment offers most benefit. The team has experience and ability in this
field and will ensure the results are well publicised. Any child can withdraw from the study
at any time.