Recruiting

Open to: All Genders

Age: Child

Medical Conditions

Severe paediatric asthma

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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.

Publications

The researchers first check that children with severe asthma are taking their inhalers using electronic monitoring. All children that have poor control despite taking their inhalers (STRA), and those who fail to take their inhalers regularly despite our best efforts to achieve this (these children are at high risk of asthma death), are eligible. The following tests are done at each visit (once a month):
1. Lung function tests (spirometry and exhaled nitric oxide): blowing and breathing tests. These are done routinely at every clinic appointment
2. Symptoms questionnaire: any asthma attacks in the last 4 weeks
3. Quality of life questionnaire: the impact of asthma on the child’s activity and emotions

The following tests are done at the first visit, then at one month and 4 months:
1. A blood test (about one teaspoon, or 5 ml) to look at the number of eosinophils
2. A sputum (phlegm) test
3. Throat swab for infection
4. A urine sample (about one teaspoon, or 5 ml) is taken and tested for cigarette smoke exposure
5. A pregnancy test - before receiving the study treatment, a pregnancy test is done but only for children who are of potential child-bearing age
The following tests are done only once at the beginning of the study:
1. Blood tests (about one teaspoon, or 5 ml) and skin tests to assess allergy status
2. Bronchoscopy samples (ONLY to be taken from children who need a bronchoscopy as part of their routine care)
2.1. This includes washings from the airways (broncho-alveolar lavage) and bronchial biopsies (tiny pieces of tissue taken from the airway wall using forceps)
2.2. There is one extra test if a child is having a bronchoscopy. This test involves taking some cells that line the walls of the airways including the nose using a special brush through the bronchoscope (for the lower airways). This test is performed routinely in children as part of normal clinical care. The brushing may cause a very small amount of bleeding. These tests will be performed at the end of the procedure and are just for research. They will take about 3 minutes.

All recruiting sites have a specialist severe asthma service for children. All school-age children aged 6-16 years referred with poor asthma control despite being prescribed maximal asthma inhaler therapy are eligible for the run-in and screening for adherence. In addition, children already attending the clinics at each site that have not yet been prescribed additional medications, or who may have had a previous failed trial of omalizumab, are eligible for the run-in as well.

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.

King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
Brighton And Sussex University Hospitals NHS Trust
Royal Sussex County Hospital Eastern Road
Brighton
BN2 5BE
NHS Lothian
Waverley Gate 2-4 Waterloo Place
Edinburgh
EH1 3EG
University Hospital Southampton NHS Foundation Trust
Mailpoint 18 Southampton General Hospital Tremona Road
Southampton
SO16 6YD
NHS Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-trent
ST4 6QG
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton Hospital Sydney Street
London
SW3 6NP
Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary Infirmary Square
Leicester
LE1 5WW
Birmingham Women's and Children's NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
Alder Hey Children's NHS Foundation Trust
Alder Hey Hospital Eaton Road West Derby
Liverpool
L12 2AP
Imperial College Healthcare NHS Trust
St Mary’s Hospital The Bays S Wharf Rd Paddington
London
W2 1NY

Participants may receive a newly licenced treatment for severe asthma that not many centres in the UK can currently prescribe. Their eligibility for omalizumab will not be restricted by the current NHS guidelines, as all children will receive at least one treatment, regardless of the current NHS rules.
The monitoring period, many of the assessments including bronchoscopy and omalizumab are part of routine clinical care. There may be some side effects from omalizumab, but these cannot be predicted, and in the researchers' experience of using it in children so far, there have been no side effects that have caused significant harm. Omalizumab can rarely cause discomfort in arms and legs, may make a patient feel dizzy or tired, result in a rash, or pain in the ears. The most common side effects known about for mepolizumab are that it can cause headache, skin reactions where the injection was given, back pain and tiredness. However, the researchers are not aware of all of the potential side effects of mepolizumab in children as it has not been used very much at all in children. It is also possible that the treatment will not benefit participants’ asthma, but this cannot be predicted and would be the same even if a patient was not in the study.

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Read full details for Trial ID: ISRCTN12109108

Or CPMS 44294

Last updated 23 August 2024

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Treating severe paediatric asthma: the TREAT trial

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Treating severe paediatric asthma: the TREAT trial

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