WheezingNCT06237660
Longitudinal Preschool Wheeze Biomarker Study
An observational study of Wheezing, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Wheezing
- What is being tested?
- Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy, Skin prick test and Finger prick blood test
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Recruitment will be from the Royal Brompton Hospital, which is a tertiary referral centre for respiratory paediatrics, but also receives direct referrals from GPs in North West London. This target population includes children from all sociodemographic and ethnic backgrounds as referrals are received from across London and the Southeast region.
Who may be able to join
- 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:
- children undergoing clinically indicated bronchoscopy, as determined by their existing medical team, as part of their standard management
Who cannot join
- Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Patrik Pettersson, p.pettersson@rbht.nhs.uk
About this study
Official title: Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze
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.
Read more
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:
- Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds)
- Finger prick blood test
- Phlegm test for bacteria
- Nose and throat swab for bacteria
- Lung function test called forced oscillation technique (FOT)
Read the detailed description
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.
- Conditions
- Wheezing
- Being tested
- Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy, Skin prick test, Finger prick blood test, Forced oscillation technique (FOT), Sputum induction
- Keywords
- Preschool wheeze, Preschool asthma, Allergy, Infection, Steroids
- Medical subject headings
- Respiratory Sounds, Hypersensitivity, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsyProcedure or surgery
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. They will be having lung samples (washings from the lung and a tiny piece of tissue taken from the breathing tubes) taken as part of their usual medical management. The research team will ask for consent to use the leftover samples for the bronchoscopy, for the study
Skin prick testDiagnostic test
To identify children with allergies. This test will not be done if the child has had allergy testing in the last 6 months
Finger prick blood testDiagnostic 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. The research team will be obtain the results within minutes, using a point-of-care device. A few more drops of blood, from the same finger prick sample, will be taken to look at how one of the blood cells work, in more detail, in the laboratory. There is no additional finger prick required for this lab test, and the drops of blood will be collected at the same time, from the same prick, as the point of care test.
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. The test will be explained to the child and completed using our established protocols. This test will only require the child to breathe in and out normally, and therefore can be done in preschool aged children. The current test that is used to check lung function called spirometry cannot be used in preschool children, as it involves following complicated instructions. The aim is to assess how well this newer lung function test is tolerated, in children aged 1-5 years.
Sputum inductionProcedure or surgery
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. The research team will obtain phlegm samples, with a quick suction after patients have inhaled the salty mist (saline nebuliser) which will help loosen up their phlegm. If the child can cough it up, they will be encouraged to do it.
Oropharyngeal swabDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation.
The aim is correlate the results from the bronchoscopy with the panel of test proposed, and evaluate if these simple bedside tests can pick up the same level of infection or inflammation and obtain the same results, as the bronchoscopy, which is a much more invasive test, but the only method available at present to get this information. Receives: Procedure: Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy; Diagnostic Test: Skin prick test; Diagnostic Test: Finger prick blood test; Diagnostic Test: Forced oscillation technique (FOT); Procedure: Sputum induction; Diagnostic Test: Oropharyngeal swab | |
| Aim 2 | The aim is to test how acceptable these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. Receives: Diagnostic Test: Skin prick test; Diagnostic Test: Finger prick blood test; Diagnostic Test: Forced oscillation technique (FOT); Procedure: Sputum induction; Diagnostic Test: Oropharyngeal swab | |
| Aim 3 | Small proof-of-concept study. This is for a feasibility trial of using the proposed tests and deciding the treatment of their wheeze, based on the results of the tests. Children with evidence of allergen sensitisation +/- blood eosinophilia (>0.3x109/L) will be prescribed regular inhaled corticosteroids. Children who are non-atopic (non-atopic is defined as blood eosinophil of <0.3x109/L + no evidence of allergen sensitisation) with positive bacterial detection in sputum, will be prescribed four weeks of targeted antibiotics. Children who are non-atopic with no bacteria detected in sputum, will be prescribed only be prescribed short acting bronchodilators as required. All medications will be prescribed, as per the British National Formulary for Children, based on age and weight.
The aims of this preliminary study are to understand whether parents will agree to be part of such an interventional trial. This will help the research team when designing a future larger clinical trial. Receives: Diagnostic Test: Skin prick test; Diagnostic Test: Finger prick blood test; Diagnostic Test: Forced oscillation technique (FOT); Procedure: Sputum induction; Diagnostic Test: Oropharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal study of skin prick tests as biomarkers of preschool wheeze
Specificity, sensitivity and longitudinal stability of skin prick tests to six common allergens (measured by size of wheal in response to skin prick, measured in mm) as a biomarker of allergen sensitisation.
Measured: 3 years
Longitudinal study of finger-prick point of care test for eosinophil count as a biomarker of preschool wheeze
Specificity, sensitivity and longitudinal stability of a finger-prick point of care test for eosinophil count (measured as cells per cubic mm) as a biomarker of eosinophilic inflammation.
Measured: 3 years
Longitudinal study of blood neutrophil phenotype as a biomarker of airway infection
Specificity, sensitivity and longitudinal stability of blood neutrophil phenotype (measured as mean fluorescence intensity for indicative phenotype markers) as a biomarker of airway infection.
Measured: 3 years
Longitudinal study of blood neutrophil chemotaxis as a biomarker of wheezing phenotype
Specificity, sensitivity and longitudinal stability of blood neutrophil chemotaxis (measured in micrometers per minute) as a biomarker of wheezing phenotype.
Measured: 3 years
Longitudinal study of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection
Specificity, sensitivity and longitudinal stability of oropharyngeal swab and induced sputum PCR (measured by detectable presence or absence of DNA from Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis) as biomarkers of airway infection. Concordance between oropharyngeal swab and induced sputum PCR results from the same patient will also be assessed.
Measured: 3 years
Longitudinal study of lung function test (FOT) as a biomarker of airway reversibility
Specificity, sensitivity and longitudinal stability of lung function test (forced oscillation technique or FOT), measured by lung reactance and lung resistance (Rrs: respiratory system resistance; Xrs: respiratory system reactance; AX: area of reactance), as biomarkers of airway reversibility in wheezing patients.
Measured: 3 years
Secondary outcomes (6)
Association between eosinophil counts and patient symptom control
Measurement of eosinophil counts (measured as cells per cubic mm) in relation to patient symptom control, using the Test for Respiratory and Asthma Control in Kids (TRACK), a caregiver-completed validated questionnaire for preschool-aged children (measured as mean symptom score). TRACK is a 5-item standardized questionnaire, with each item being scored from 0 to 20 points on a 5-point Likert-type scale. Total score ranging from 0 to 100. Higher scores indicate better respiratory and asthma control; a score of less than 80 points suggests that a child's breathing problems might not be controlled.
Measured: 3 years
Patient acceptability of finger prick blood eosinophil count as a non-invasive biomarker in preschool wheeze
Determining the patient acceptability of finger prick blood eosinophil count as a non invasive biomarker test, using the Visual Analogue Scale (VAS) of pain intensity. The scale ranges from 0 to 10, with 0 being no pain or discomfort and 10 for worst pain possible. Higher scores indicate worse tolerability.
Measured: 3 years
Patient acceptability of skin prick test as a non-invasive biomarker in preschool wheeze
Determining the patient acceptability of skin prick test as a non invasive biomarker test, using the Visual Analogue Scale (VAS) of pain intensity. The scale ranges from 0 to 10, with 0 being no pain or discomfort and 10 for worst pain possible. Higher scores indicate worse tolerability.
Measured: 3 years
Patient acceptability of forced oscillation technique as a non-invasive biomarker to determine lung function and airway reversibility in preschool wheeze
Determining the patient acceptability of forced oscillation technique as a non invasive biomarker test, to determine lung function and airway reversibility in preschool children, using the Visual Analogue Scale (VAS) of pain intensity. The scale ranges from 0 to 10, with 0 being no pain or discomfort and 10 for worst pain possible. Higher scores indicate worse tolerability.
Measured: 3 years
Patient acceptability of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection in preschool wheeze
Determining the patient acceptability of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection in preschool children, using the Visual Analogue Scale (VAS) of pain intensity. The scale ranges from 0 to 10, with 0 being no pain or discomfort and 10 for worst pain possible. Higher scores indicate worse tolerability.
Measured: 3 years
Correlation between eosinophil counts and symptom burden of preschool wheeze to caregivers
Correlation between measurement of eosinophil counts (measured as cells per cubic mm) and assessment of symptom burden of preschool wheeze to caregivers using the validated Paediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ), measured by mean life quality score. This is a questionnaire that is self-administered by the caregiver, and assess symptom burden to caregivers, across two domains (activity limitations and emotional function). Each question is assessed using a 7-point Likert scales, with 1 indicating severe impairment and 7 indicating no impairment. Domains scores are calculated as the mean score across items in that domain. The overall score is the mean score across all items. The lowest score achievable is 1 and highest score achievable is 7, and higher scores indicate better quality of life.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WheezingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Action Medical Research, Masonic Charitable Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sejal Saglani, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237660
- Sponsor's protocol ID
- 23IC8468
- Other IDs
- GN3005
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Clinical data that is needed for analysis and integration into the project will only be used in a pseudonymised fashion. All subjects will be given study identifier numbers. This data set as well as data dictionaries, will the be made available to the other members of the research team, eg, statisticians for data analysis
Publications
Robinson PFM, Fontanella S, Ananth S, Martin Alonso A, Cook J, Kaya-de Vries D, Polo Silveira L, Gregory L, Lloyd C, Fleming L, Bush A, Custovic A, Saglani S. Recurrent Severe Preschool Wheeze: From Prespecified Diagnostic Labels to Underlying Endotypes. Am J Respir Crit Care Med. 2021 Sep 1;204(5):523-535. doi: 10.1164/rccm.202009-3696OC.
PubMed 33961755
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze
- ClinicalTrials.gov ID
- NCT06237660
- Acronym / sponsor ID
- 23IC8468
- Conditions
- Wheezing
- Keywords
- Preschool wheeze, Preschool asthma, Allergy, Infection, Steroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Action Medical Research, Masonic Charitable Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds)
- Finger prick blood test
- Phlegm test for bacteria
- Nose and throat swab for bacteria
- Lung function test called forced oscillation technique (FOT)
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | – | Procedure: Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy, Diagnostic Test: Skin prick test, Diagnostic Test: Finger prick blood test, Diagnostic Test: Forced oscillation technique (FOT), Procedure: Sputum induction, Diagnostic Test: Oropharyngeal swabTo test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation. The aim is correlate the results from the bronchoscopy with the panel of test proposed, and evaluate if these simple bedside tests can pick up the same level of infection or inflammation and obtain the same results, as the bronchoscopy, which is a much more invasive test, but the only method available at present to get this information. |
| Aim 2 | – | Diagnostic Test: Skin prick test, Diagnostic Test: Finger prick blood test, Diagnostic Test: Forced oscillation technique (FOT), Procedure: Sputum induction, Diagnostic Test: Oropharyngeal swabThe aim is to test how acceptable these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. |
| Aim 3 | – | Diagnostic Test: Skin prick test, Diagnostic Test: Finger prick blood test, Diagnostic Test: Forced oscillation technique (FOT), Procedure: Sputum induction, Diagnostic Test: Oropharyngeal swabSmall proof-of-concept study. This is for a feasibility trial of using the proposed tests and deciding the treatment of their wheeze, based on the results of the tests. Children with evidence of allergen sensitisation +/- blood eosinophilia (>0.3x109/L) will be prescribed regular inhaled corticosteroids. Children who are non-atopic (non-atopic is defined as blood eosinophil of <0.3x109/L + no evidence of allergen sensitisation) with positive bacterial detection in sputum, will be prescribed four weeks of targeted antibiotics. Children who are non-atopic with no bacteria detected in sputum, will be prescribed only be prescribed short acting bronchodilators as required. All medications will be prescribed, as per the British National Formulary for Children, based on age and weight. The aims of this preliminary study are to understand whether parents will agree to be part of such an interventional trial. This will help the research team when designing a future larger clinical trial. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Recruitment will be from the Royal Brompton Hospital, which is a tertiary referral centre for respiratory paediatrics, but also receives direct referrals from GPs in North West London. This target population includes children from all sociodemographic and ethnic backgrounds as referrals are received from across London and the Southeast region.
Key inclusion criteria (6 listed)
- 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.
- children undergoing clinically indicated bronchoscopy, as determined by their existing medical team, as part of their standard management
Key exclusion criteria (1 listed)
- Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsyThese 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. They will be having lung samples (washings from the lung and a tiny piece of tissue taken from the breathing tubes) taken as part of their usual medical management. The research team will ask for consent to use the leftover samples for the bronchoscopy, for the study | Procedure or surgery | Aim 1 |
| Skin prick testTo identify children with allergies. This test will not be done if the child has had allergy testing in the last 6 months | Diagnostic test | Aim 1, Aim 2, Aim 3 |
| Finger prick blood testFinger 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. The research team will be obtain the results within minutes, using a point-of-care device. A few more drops of blood, from the same finger prick sample, will be taken to look at how one of the blood cells work, in more detail, in the laboratory. There is no additional finger prick required for this lab test, and the drops of blood will be collected at the same time, from the same prick, as the point of care test. | Diagnostic test | Aim 1, Aim 2, Aim 3 |
| Forced oscillation technique (FOT)Breathing test will be performed using forced oscillation technique (FOT), to see how the child's lungs work and to detect airway inflammation. The test will be explained to the child and completed using our established protocols. This test will only require the child to breathe in and out normally, and therefore can be done in preschool aged children. The current test that is used to check lung function called spirometry cannot be used in preschool children, as it involves following complicated instructions. The aim is to assess how well this newer lung function test is tolerated, in children aged 1-5 years. | Diagnostic test | Aim 1, Aim 2, Aim 3 |
| Sputum inductionSputum 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. The research team will obtain phlegm samples, with a quick suction after patients have inhaled the salty mist (saline nebuliser) which will help loosen up their phlegm. If the child can cough it up, they will be encouraged to do it. | Procedure or surgery | Aim 1, Aim 2, Aim 3 |
| Oropharyngeal swabSwabs 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 | Diagnostic test | Aim 1, Aim 2, Aim 3 |
Primary outcome
Longitudinal study of skin prick tests as biomarkers of preschool wheeze
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of skin prick tests to six common allergens (measured by size of wheal in response to skin prick, measured in mm) as a biomarker of allergen sensitisation.
Longitudinal study of finger-prick point of care test for eosinophil count as a biomarker of preschool wheeze
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of a finger-prick point of care test for eosinophil count (measured as cells per cubic mm) as a biomarker of eosinophilic inflammation.
Longitudinal study of blood neutrophil phenotype as a biomarker of airway infection
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of blood neutrophil phenotype (measured as mean fluorescence intensity for indicative phenotype markers) as a biomarker of airway infection.
Longitudinal study of blood neutrophil chemotaxis as a biomarker of wheezing phenotype
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of blood neutrophil chemotaxis (measured in micrometers per minute) as a biomarker of wheezing phenotype.
Longitudinal study of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of oropharyngeal swab and induced sputum PCR (measured by detectable presence or absence of DNA from Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis) as biomarkers of airway infection. Concordance between oropharyngeal swab and induced sputum PCR results from the same patient will also be assessed.
Longitudinal study of lung function test (FOT) as a biomarker of airway reversibility
Time frame: 3 years
Specificity, sensitivity and longitudinal stability of lung function test (forced oscillation technique or FOT), measured by lung reactance and lung resistance (Rrs: respiratory system resistance; Xrs: respiratory system reactance; AX: area of reactance), as biomarkers of airway reversibility in wheezing patients.
6 secondary outcomes
Association between eosinophil counts and patient symptom control
Time frame: 3 years
Patient acceptability of finger prick blood eosinophil count as a non-invasive biomarker in preschool wheeze
Time frame: 3 years
Patient acceptability of skin prick test as a non-invasive biomarker in preschool wheeze
Time frame: 3 years
Patient acceptability of forced oscillation technique as a non-invasive biomarker to determine lung function and airway reversibility in preschool wheeze
Time frame: 3 years
Patient acceptability of oropharyngeal swab and induced sputum PCR as a biomarker of airway infection in preschool wheeze
Time frame: 3 years
Correlation between eosinophil counts and symptom burden of preschool wheeze to caregivers
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 33961755Robinson PFM, Fontanella S, Ananth S, Martin Alonso A, Cook J, Kaya-de Vries D, Polo Silveira L, Gregory L, Lloyd C, Fleming L, Bush A, Custovic A, Saglani S. Recurrent Severe Preschool Wheeze: From Prespecified Diagnostic Labels to Underlying Endotypes. Am J Respir Crit Care Med. 2021 Sep 1;204(5):523-535. doi: 10.1164/rccm.202009-3696OC.
- Individual participant dataSharing planned: Yes. Clinical data that is needed for analysis and integration into the project will only be used in a pseudonymised fashion. All subjects will be given study identifier numbers. This data set as well as data dictionaries, will the be made available to the other members of the research team, eg, statisticians for data analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sejal Saglani, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheuk Fung Wong (+4420 7594 9832, cheuk-fung.wong@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal study of skin prick tests as biomarkers of preschool wheeze (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.