Mild asthma Respiratory Asthma
Conditions
Interventions
The ASYMPTOMATIC trial is a pragmatic non-inferiority open-label RCT with a 1:1 participant allocation ratio, in general practices across the UK that are registered with the Clinical Practice Research
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 - 15 years inclusive 2. Mild asthma, including children with a new diagnosis. 3. At least one relevant (for asthma) prescription of short acting beta agonists (SABA) or inhaled corticosteroids (ICS) in the last 12 months (including new diagnoses) 4. Written and informed consent and assent from the participant’s legal representative and participant respectively (for participants under 16 years of age)and agreement of the participant to comply with the requirements of the trial 5. Ability of the parent, and young person where appropriate, to complete patient reported outcomes in English
Exclusion criteria
Exclusion criteria: 1. Hospitalised for asthma in the last 12 months (this does not include children who have attended the ED but not been admitted) 2. Three or more asthma attacks treated with oral corticosteroids in the last 12 months 3. Significant respiratory comorbidity including cystic fibrosis, immunodeficiency or interstitial lung disease 4. Prescribed, or taking, any of the following at the time of randomisation: montelukast, long acting beta-agonist whether in combination with ICS or as a separate inhaler, azithromycin (given prophylactically). Patients who have previously received these treatments but who are no longer receiving them at the time of randomisation i.e. treatment has been stepped down, are not excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of asthma attacks requiring treatment with OCS in the 12-months after randomisation. Information on this outcome will be obtained from prescription records and through linkage with Hospital Episode Statistic (HES) data. 2. Cost per QALY gained (ICER) over the 12 month treatment/follow up period measured using: 2.1. CHU-9D questionnaire responses at baseline, 4, 8- and 12-months 2.3. Resource use from HES and CPRD data at the end of the trial 2.4. For utilities: application of UK tariff scores 2.5. For QALYs: area under the utility-time curve 2.6. For costs: sum-product of all measured items of resource use and their respective NHS unit costs ICER calculated as the difference in total costs between intervention groups, divided by the difference in QALYs. | — |
Secondary
| Measure | Time frame |
|---|---|
| At 4, 8 and 12 months after randomisation 1. Asthma control measured using Asthma Control Test (ACT) 2. Participant adherence to the intervention (adherence questionnaire) 3. Health utility (CHU9D tool) 4. Cumulative dose of ICS over the 12 month treatment period (estimated from the number of ICS inhalers prescribed, as indicated from prescription records) 5. Treatment failure (i.e. when LABA or LTRA additional preventer therapies were prescribed, as determined from prescription records) 6. Hospitalisation and mortality will be identified from linked HES data 7. Serious Adverse Events (SAEs). SAEs will be reviewed by the CI and Suspected Unexpected Serious Adverse Reactions (SUSARs) reported accordingly by GPs | — |
Countries
England, United Kingdom
Contacts
Public ContactRichard Kirk
Outcome results
None listed