We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Sejal
Saglani
+44 (0)2075943167
s.saglani@imperial.ac.uk
Dr
Claire
Streatfield
+44 (0)207 594 3403
treat_trial@imperial.ac.uk
Severe paediatric asthma
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
2-5% of children with asthma have repeated hospital admissions with asthma attacks, school absences and poor quality of life despite being prescribed maximal doses of treatment. A period of treatment monitoring using an electronic device can distinguish patients that have improved control when they take their inhalers properly from those who remain poorly controlled despite taking their treatment; severe therapy-resistant asthma (STRA).
Apart from high-dose steroids, which result in severe side effects, there are two medications licensed as add-on treatments in children with STRA. Both are given as regular injections in hospital. Omalizumab can currently only be used in about 60% of children with STRA because prescribing is limited by a blood test called IgE that is related to allergies and also the child’s weight. Of those in whom omalizumab can be tried, only about half respond. Mepolizumab was licenced for use in children in 2018. Although safety and the doses have been evaluated, no studies have assessed whether it helps children with STRA. The aim of this study is to determine whether mepolizumab is as efficacious as omalizumab in reducing asthma attacks in children with STRA and refractory DA.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant exclusion criteria as of 10/09/2020:1. Considered unfit for the study or risk of noncompliance with study procedures by the responsible physician as a result of medical interview, physical examination or screening investigation2. Known hypersensitivity to Omalizumab or Mepolizumab or to any of the excipients3. History of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation4. Pregnant, lactating or within 6 weeks post-partum or breast feeding5. Participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures6. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the main diagnosis; they can be present in addition to asthma major problem rather than in addition to severe asthma) 7. Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease8. Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)
Previous participant exclusion criteria:1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study or has a risk of non-compliance with study procedures2. The child has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation3. Participant is female who is pregnant, lactating or within 6 weeks post-partum or breastfeeding4. The child has participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures5. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)6. Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease7. Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Claire
Streatfield
+44 (0)207 594 3403
treat_trial@imperial.ac.uk
Prof
Sejal
Saglani
+44 (0)2075943167
s.saglani@imperial.ac.uk
The study is sponsored by Imperial College London and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/60/51; National Institute for Health Research (NIHR) (UK).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 44294
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
