At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy (procedure), Skin prick test (diagnostic test), Finger prick blood test (diagnostic test), Forced oscillation technique (FOT) (diagnostic test)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy — procedure: These children who will be having a bronchoscopy (a long thin tube, with a camera at the end, which is put inside the lung to look at and collect samples) as part of their standard clinical management, determined by their own consultants or treating physicians. · Skin prick test — diagnostic test: To identify children with allergies. · Finger prick blood test — diagnostic test: Finger prick testing will be used for blood samples, and it is the same technique used by children with diabetes, to test their blood sugar levels, and therefore is regularly used in this age group successfully. · Forced oscillation technique (FOT) — diagnostic test: Breathing test will be performed using forced oscillation technique (FOT), to see how the child's lungs work and to detect airway inflammation. · Sputum induction — procedure: Sputum induction is a test of obtaining phlegm after inhalation of salt water mist (saline nebuliser) and this will allow the research team to look for any relationships between infection in the lungs and the accuracy of the less invasive, nose and throat swabs. · Oropharyngeal swab — diagnostic test: Swabs from children's nose and throats (similar to swab tests that are done for Covid tests), that will be used to test for bacterial infection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 1 Year to 5 Years
- Who
- All
- Number of participants
- 150
- Started
- 2024-02-01
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for wheezing
- • Clinical study - 150 participants
- • Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations
Who can take part?
- • Ages 1 Year to 5 Years
- • Diagnosed with wheezing
Where?
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child. The goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group. The research team would like to investigate the following aims: Aim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation. Aim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. Aim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child. The panel of simple non-invasive tests that the research team are proposing are: 1. Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds) 2. Finger prick blood test 3. Phlegm test for bacteria 4. Nose and throat swab for bacteria 5. Lung function test called forced oscillation technique (FOT)
More detail
Research Question: Can the research team identify simple bedside tests that can give quick, accurate results while being acceptable to parents and children, and can these tests be successfully used in clinical practice, to decide treatment for preschool wheeze? Participants will be asked to do these simple tests- skin prick test, finger prick blood test, breathing test, throat swab, and a test to catch their phlegm. The researchers will use two tests to identify children who are likely to respond to inhaled steroids: skin tests for allergies and a finger prick blood test. To identify children with bacterial infections in their lungs, where antibiotics will be useful, the team will obtain a sample of sputum (phlegm) after a salty mist inhalation (saline nebuliser), and will test the accuracy of a throat swab that detects bacteria. The research team will also test how cells called neutrophils work in children without allergies or infection with the same finger prick blood test above. A breathing test called forced oscillation will be used to identify children who may respond to their reliever "blue" inhaler during wheezing attacks. The research team will also recruit a small number of children, for a trial in which their treatment will be guided by their test result, to see if parents are willing to take part in such a study, before designing a larger trial. This study will be the first to show that new tests can identify different types of preschool wheezing and can be used to plan treatment based on individual children's needs. Researchers will compare to see if children who have their treatment based on the simple bedside tests do better than the children who are just given inhaled steroids.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Year - 5 Years
- Who can join: All genders
What the study is looking for
- ✓Aim 1, 2 and 3:
- ✓Children aged 1-5 years
- ✓More than 2 hospitalisations for acute wheeze in the last year or
- ✓At least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year.
- ✓Aim 1 only:
Who cannot take part
- ✗Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis.
See the full criteria
Where Is This Study? (1 UK site)
Royal Brompton Hospital
London SW3 6NP, United Kingdom
How to Get in Touch
Cheuk Fung Wong
Sponsor contactCONTACT