Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 300524 | Registry Identifier | IRAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Asthma UK Centre for Applied Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. That is because only some preschool children have the type of inflammation (known as Type 2 inflammation) that responds to ICS, thus many children are being unnecessarily exposed to side effects. It is difficult diagnosing Type 2 inflammation through history and examination, thus other indicators are needed to ensure ICS are only given to children who will benefit. These indicators are commonly known as biomarkers, and we are trying to find out if they are useful. We want to measure three biomarkers, without changing children's treatment. The first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). The second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. The final biomarker is a molecule that is produced in the airways of preschool children with Type 2 inflammation, called nitric oxide (NO). This is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring NO later on. The children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. The results will form the basis of the design of a national trial of biomarker-driven therapy in such children.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preschool children with a history of wheeze, aged 1 to 5 years old | This is a pragmatic, observational study involving preschool children with wheeze aged one to five years old. All treatment and routine monitoring decisions will be at the discretion of their treating general practitioner (GP) or paediatrician (as per usual clinical practice), blinded to the study measurements. The following three biomarker tests will be performed a) atopic sensitisation, b) blood eosinophil count and c) FeNO (off-line method). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood eosinophil count | Diagnostic Test | Peripheral blood eosinophil count will be measured from a finger prick blood sample, using the Haemocue machine, allowing a result in approximately 2 minutes. The test will allow to assess the presence or not of eosinophilia and if it can predict future wheezing exacerbations and response to inhaled corticosteroids (ICS). |
| Measure | Description | Time Frame |
|---|---|---|
| Wheeze Attacks | Defined as requiring an unscheduled healthcare visit to the ED or GP. | 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Days Out of Nursery | Children unable to attend childcare facility due to a wheeze attack. There were no arms in this study, only a single group followed in an identical manner. | 1 year follow-up period |
| Parents Days Out of Work |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Biomarker Tests by Parents | The acceptability of the three biomarker tests by parents to be used in clinical practice was assessed through focus group discussions. | 12-months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children aged one to five years old presenting either to primary care with wheezing episodes or to emergency departments or urgent care centres with an acute attack of wheeze or children identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Bush, MD FHEA FRCP FRCPCH FERS FAPSR | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
Only children 1-5 years old were considered enrolled. Their parents/guardians were not considered as enrolled. They signed the consent form for enrolment and complete the monthly questionnaires during follow-up on behalf of their child. No interventions were performed in this study. There were no arms in this study, only a single group followed in an identical manner.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Preschool Children Aged 1 to 5 Years Old | Preschool children with a history of ≥1 doctor-diagnosed acute wheeze attack of any severity, in the year prior to baseline measurement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data on children's age, gender and ethnicity were provided by their parents. The baseline analyses apply only to preschool children aged 1-5 years old (not their parents).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Preschool Children Aged 1 to 5 Years Old | Preschool children with a history of ≥1 doctor-diagnosed acute wheeze attack of any severity, in the year prior to baseline measurement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wheeze Attacks | Defined as requiring an unscheduled healthcare visit to the ED or GP. | Data only applies to children aged 1-5 years old. There were no arms in this study, only a single group followed in an identical manner. | Posted | Median | Full Range | Wheeze attacks | 1-year follow-up |
|
|
Only during biomarker testing (i.e., at single baseline visit and at second visit 3 months post-baseline)
Adverse events were recorded for the biomarker measurements but not during the observation period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preschool Children Aged 1 to 5 Years Old | Adverse events were recorded for the biomarker measurements (i.e., at single baseline visit and at second visit 3 months post-baseline) but not during the observation period. |
Not provided
Not provided
FeNO measurements were not obtained in all children due to delayed appreciation that the gas collection bag was faulty. However, a mitigation strategy was utilised to increase the number of children who had FeNO recorded. Children with FeNO measurement at baseline and those with a FeNO measurement in the second, but not baseline testing were combined, giving 68 children with FeNO measurements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Andrew Bush | Imperial College London | 020 7352 8121 | 2255 | a.bush@imperial.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2023 | Nov 29, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089142 | Fractional Exhaled Nitric Oxide Testing |
| ID | Term |
|---|---|
| D001944 | Breath Tests |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Atopic sensitization | Diagnostic Test | Skin prick tests will be performed to: (a) house dust mite, (b) grass pollen, (c) tree pollen, (d) cat hair, (e) dog hair, as well as normal saline and histamine which will act as negative and positive controls respectively. In addition, skin prick tests will allow the assessment of which aeroallergen is the most useful predictor of outcomes in preschool children. |
|
| FeNO (offline method) | Diagnostic Test | The child will breathe normally into a sample bag that will be collected for later analysis of FeNO levels. The test will be performed twice. |
|
Days out of work parents needed to take because of their child's wheeze attack. There were no arms in this study, only a single group followed in an identical manner.
| 1 year follow-up period |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Blood eosinophil count | Median | Full Range | cells/μL |
|
| Fractional exhaled nitric oxide | Median | Full Range | ppb |
|
| Atopy | Count of Participants | Participants |
|
|
|
| Secondary | Days Out of Nursery | Children unable to attend childcare facility due to a wheeze attack. There were no arms in this study, only a single group followed in an identical manner. | Data only applies to children aged 1-5 years old and not their parents. There were no arms in this study, only a single group followed in an identical manner. | Posted | Median | Full Range | days | 1 year follow-up period |
|
|
|
| Secondary | Parents Days Out of Work | Days out of work parents needed to take because of their child's wheeze attack. There were no arms in this study, only a single group followed in an identical manner. | Data only apply to parents of preschool children. There were no arms in this study, only a single group followed in an identical manner. Every month parents would be asked to state whether they needed to take any days of work due to their child's wheeze. | Posted | Median | Full Range | days | 1 year follow-up period |
|
|
|
| Other Pre-specified | Acceptability of Biomarker Tests by Parents | The acceptability of the three biomarker tests by parents to be used in clinical practice was assessed through focus group discussions. | Only 16 out of 95 parents agreed to participate in these focus group discussions. | Posted | Count of Participants | Participants | 12-months |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
Not provided
Not provided