Asthma Respiratory Asthma
Conditions
Interventions
Eligible and consenting participants will be randomised to one of the two groups (treatment decisions based on FeNO plus symptoms [interventional arm] or treatment decisions based on symptoms alone [s
Sponsors
University of Aberdeen and NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Asthma diagnosed or confirmed by consultant paediatrician (or Read code for asthma if recruited in primary care) 2. Aged 6 years or older and not yet reached the date of their 16th birthday 3. Currently prescribed inhaled corticosteroids (<1000mcg budesonide equivalent per day in those <12 years; <2000 mcg budesonide equivalent per day for older children) 4. At least one patient/parent reported-asthma exacerbation treated with oral corticosteroids in the 12 months prior to recruitment
Exclusion criteria
Exclusion criteria: 1. Unable to provide FeNO measurement at baseline assessment (expected prevalence <5%) 2. Other chronic respiratory conditions which also have exacerbations 3. Current treatment with maintenance oral steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/02/2021: Asthma exacerbation (attack) requiring prescription (and/or use of) one or more course of OCS in the 12 months after randomisation (yes/no). Outcomes will be assessed at the 3, 6, 9 and 12 months follow-up visits. In protocol version 3 (31 August 2017) we refined the definition of the primary outcome to reflect a change in treatment, where some exacerbations were being treated with a single dose of oral corticosteroid; and clarified that the primary source of information on exacerbations would be the child and parent or carer; with GP records used only where this information was missing. _____ Previous primary outcome measure: Asthma exacerbation (attack) requiring prescription of OCS for 3-7 consecutive days determined from a patient held diary and verified by GP records where possible in the 12 months after randomisation (yes/no). Outcomes will be assessed at the 3, 6, 9 and 12 months follow-up visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first exacerbation is determined from the child/parent or carer and from GP records in the 12 months after randomisation. Outcomes will be assessed at 3, 6, 9 and 12 months post randomisation 2. Number of exacerbations during follow up, based on prescribed oral corticosteroid, is assessed by responses to asthma attacks that have required oral steroid tablets on the follow-up CRF at 3,6,9, and 12 months follow-up determined from the child/parent or carer and from GP records in the 12 months after randomisation 3. Need for unscheduled healthcare assessment during follow up (yes/no) is measured by responses to health service use on the follow-up CRF at 3,6,9 and 12 months follow-up determined from the child/parent or carer and from GP records in the 12 months after randomisation 4. Number of unscheduled health assessments is measured by responses on the follow-up CRF to health service use at 3,6,9 and 12 months follow-up determined from the child/parent or carer and from GP records in the 12 months after randomisation 5. Asthma control during follow up (i.e. age-appropriate Asthma Control Test score) is assessed by responses to the Asthma Control Test (ACT)/Children’s Asthma Control Test (CACT) - questionnaires completed by child/parent or carer at baseline, and at 3, 6, 9 and 12 month follow-up appointments 6. Asthma severity (%FEV1) is measured using spirometry at baseline and at 3, 6, 9 and 12 month follow-up appointments. 7. Fractional exhaled nitric oxide (FeNO) is measured by Niox Vero device at baseline, and 3, 6, 9 and 12 month follow-up appointments 8. Dose of ICS during the 12 months follow up (i.e. daily dose of budesonide equivalent averaged over 3 months) is assessed from current asthma treatment and from adherence to treatment (measured using adherence monitors); this data is collected at 3, 6, 9 and 12 months follow-up 9. Health status is assessed using the Paediatric Asthma Quality of Life Questionnaire (PAQLQ); a questionnaire completed by | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactJess Wood
Outcome results
None listed