Asthma Respiratory
Conditions
Interventions
We will invite eligible children to take part in our study. We hope to be able to recruit children at up to 40 hospital-based asthma clinics and primary care practices across the UK.
We aim to recrui
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 15 years old 2. Asthma diagnosis confirmed by a doctor or a respiratory/asthma specialist nurse (or Read code for asthma if recruited in primary care) 3. Patient/parent reported-asthma attack treated with at least one course of oral corticosteroids in the 12 months prior to recruitment 4. Be able to perform spirometry 5. Be able to understand written/spoken English
Exclusion criteria
Exclusion criteria: 1. Not being able to perform spirometry satisfactorily 2. Presence of another chronic respiratory condition (e.g. cystic fibrosis) 3. Current treatment with maintenance oral steroids and biologicals (we cannot provide standardised step-up/down treatment options)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma attacks in children with spirometry plus asthma control (symptoms) compared with asthma control (symptoms) alone measured using participant-reported asthma attacks that require treatment with 1-7 days of oral corticosteroids and/or intravenous corticosteroids up to 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy in children receiving spirometry plus asthma control (symptoms) compared with asthma control (symptoms): 1.1. Any asthma attack measured using participant-reported asthma attacks up to 12 months – data collected at each follow-up, 3, 6, 9, 12 months 1.2. Time to a first asthma attack measured using participant reported first asthma attack up to 12 months – data collected at each follow-up, 3, 6, 9, 12 months 1.3. Health-related quality of life measured using Paediatric Asthma QoL Questionnaire at 12 months only 1.4. Asthma control (symptoms) measured using Asthma Control Test/Children’s Asthma Control Test up to 12 months – data collected at each follow-up, 3, 6, 9, 12 months 1.5. Adverse events measured using participant-reported events up to 12 months 1.6 Dose of inhaled corticosteroids measured using participant reported dose of inhaled corticosteroid up to 12 months 2. Mechanism of action in children receiving spirometry plus asthma control (symptoms) compared with asthma control (symptoms) alone: 2.1. Airflow (FEV1) measured using spirometry up to 12 months – data collected at baseline and each follow-up, 3, 6, 9, 12 months 2.2. Lung volume (FVC) measured using spirometry up to 12 months – data collected at baseline and each follow-up, 3, 6, 9, 12 months 2.3. Eosinophilic airway inflammation (fractional exhaled nitric oxide, FeNO) measured using the FeNO test up to 12 months – data collected at baseline and each follow-up, 3, 6, 9, 12 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed