Severe acute asthma Respiratory
Conditions
Interventions
All trial participants will be having a severe asthma attack and not getting better with inhaled medications so will be classed as a medical emergency. All eligible patients will be entered into the t
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. CYP aged 2-18 years (up to and including the day prior to 19th birthday). 2. Previous clinical diagnosis of asthma or presenting with acute wheeze which the assessing healthcare professional considers to relate to underlying asthma. 3. Clinically unresponsive to maximal inhaled bronchodilator therapy (this would usually include three back-to-back doses of inhaled high-dose salbutamol plus any amount of ipratropium) or is so severe (critical asthma) that IV treatment is needed immediately.
Exclusion criteria
Exclusion criteria: 1. Immediate need for invasive ventilatory support 2. Co-existing long-term respiratory conditions (e.g. cystic fibrosis) or requiring long-term supplemental oxygen therapy 3. Known severe renal or liver disease 4. Uncorrected cyanotic congenital cardiac disease 5. Known neuromuscular disease 6. Participants where the use of intravenous (IV) aminophylline, magnesium sulfate or salbutamol would be contraindicated according to the relevant summary of product characteristics (SmPC), including known hypersensitivity or history of severe allergic reaction to any of the trial medications or their excipients 7. Known previous randomisation into the EVITA trial 8. Already received IV therapy for an episode of acute asthma during current hospital admission, or within the last 10 days 9. Currently receiving regular theophylline or other xanthine medication 10. Currently receiving beta-blockers 11. Involved with a trial of a medicinal product within the last 3 months 12. Participants or parents/carers request not to be included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Assessment of wheeze, accessory muscle use and heart rate will be used to calculate the Asthma Severity Score (ASS) at 1 and 2 hours after randomisation. This will be repeated at 4, 8, 12, 24, 48 and 72 hours post randomisation. Primary economic endpoint: Incremental cost per quality-adjusted life year (QALY) gained based on an NHS and personal social service (PSS) perspective. The analysis will adopt the perspective of the NHS and personal social services (PSS), over a time horizon of 1-month post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. Length of stay in hospital (hours) measured from randomisation to hospital discharge 2. Number of nights in hospital measured from randomisation to hospital discharge 3. Acceptability of intervention measured using the Acceptability of Intervention Measure (AIM) participant questionnaire at 30-day follow-up 4. Intervention Appropriateness Measure (IAM) measured using the IAM participant questionnaire at 30-day follow-up 5. Feasibility of Intervention Measure (FIM) measured using the FIM participant questionnaire at 30-day follow-up 6. Escalation of therapy during the admission (e.g. additional intravenous bronchodilator, non-invasive or invasive ventilatory support) measured from randomisation to hospital discharge 7. Admission to high dependency or intensive care measured from randomisation to 30-day follow-up 8. Non-invasive ventilation measured from randomisation to 30-day follow-up 9. Invasive ventilation measured from randomisation to 30-day follow-up 10. Readmission within 30 days measured at 30-day follow-up 11. Adverse events measured from randomisation to 30-day follow-up 12. Health utility based on responses to the CHU-9D and health services utilisation measured from randomisation to 30-day follow-up Tertiary/exploratory endpoints: The primary care secondary end points will serve as outcome measures for the tertiary/exploratory objectives, which focus on serum salbutamol concentration pre-IMP administration, specific polymorphisms and other patient factors, and season of presentation. Blood gas results (pH, carbon dioxide, lactate) and serum potassium measured during the hospital stay will serve as the outcome for the lactic acid objective. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactEVITA Trial Team
Outcome results
None listed