PAPA
Research type
Research Study
Full title
Preventing childhood Asthma using Prophylactic house dust mite Allergen immunotherapy
IRAS ID
1012148
Contact name
Syed Arshad
Contact email
Sponsor organisation
University of Southampton
Research summary
Asthma is common in the UK. It often starts in early childhood and can cause lifelong illness. We cannot currently reduce the risk of developing asthma. Allergen Immunotherapy (AIT) is a treatment commonly used for people to tolerate things that trigger their allergies. House dust mite (HDM) is the most common allergen for children with asthma. We think that the chance of developing asthma can be greatly reduced by giving HDM allergen in purified form to these children. We propose to recruit 434 infants aged 5 to 12 months across NHS sites in the UK. Infants can be approached before 5 months but must be at least 4 months old to undergo screening visit assessments and must be at least 5 months old (maximum 12 months old) at the time of randomisation. They will all have a close relative with asthma or allergy and/or already have early signs of an allergy such as having eczema. This means that they are much more likely to develop asthma than other infants. They will be allocated by chance to receive either the HDM tablet or placebo. The tablet dissolves within seconds and our experience with this medication is that there is no risk of choking. This treatment would be given once a day for 3 years. All infants will be reviewed every 6 weeks by telephone/video call, in the first year and then every 3 months. The researchers will be contactable 24 hours a day and if there are any concerns, they will arrange an in-person visit to the hospital clinic. Each year, children will also be seen in clinic to complete a questionnaire and have allergy tests. A breathing test will be done at the last visit. We would like to take a sample of blood when the child is recruited at the beginning of the study and at their last visit. All this information will allow us to decide whether or not each child has developed allergic wheeze by the end of the trial, which is an early indicator of later childhood asthma.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0185
Date of REC Opinion
10 Sep 2025
REC opinion
Further Information Favourable Opinion