Omalizumab in Asthma
Research type
Research Study
Full title
Is there sustained effectiveness in treating childhood asthma with omalizumab and does this relate to eosinophil or IgE levels?
IRAS ID
275225
Contact name
Tim Lee
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
Omalizumab has been approved since 2013 as an additional treatment for children with severe asthma. Several trials have been published examining its effectiveness and suggest benefits in children. However, there is little information about longer term (more than 1 year) effectiveness in terms of reducing asthma exacerbations and dosage of other medicines used to treat asthma such as steroids which can have side effects. In addition, there is little information about predicting and identifying patients likely to respond to omalizumab.
The aim of the study is to answer the following questions:
1) What is the clinical progress over time in children prescribed omalizumab?
2) Does omalizumab result in a reduced number of asthma exacerbations requiring hospital admission, treatment escalation over time?
3) Does this lead to a sustained reduction in the dose of inhaled steroids or inhaler usage over time?
4) Are there any markers to predict likelihood of response to omalizumab?This research will be conduced via a case note review of children prescribed omalizumab at two tertiary paediatric centres in England. This will have been decided by their consultant paediatrician. Data will have been collected as part of their routine clinical care. No additional procedures will need to be undertaken.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0061
Date of REC Opinion
12 Feb 2020
REC opinion
Unfavourable Opinion