23/43 Management of severe acute asthma in children commissioning brief

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the clinical and cost-effectiveness of intravenous bronchodilators in children with severe acute asthma unresponsive to maximal inhaled therapy?

1. Patient group: Children and young people aged 2-18 years with acute severe asthma unresponsive to maximal inhaled therapy requiring intravenous bronchodilators. Applicants to define and justify.
   Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
2. Interventions: IV bronchodilators – magnesium sulphate, salbutamol, and aminophylline, to be compared against each other. Applicants could consider whether there is scope to include a question about personalised medicine.
3. Important outcomes: Pediatric Asthma Severity Scores, Pediatric Respiratory Assessment Measure, admission to PICU/HDU, quality of life, patient acceptability, parent and carer acceptability, cost-effectiveness. Other outcomes: Need for non-invasive ventilation, oxygen saturations in air during treatment, amount of subsequent inhaled bronchodilator given, hospital admission, length of hospital stay, adverse events. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex, plus other demographic factors where relevant. 
4. Setting: Secondary care.
5. Study design:  A 3-arm randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop and go criteria should be provided to inform progression from pilot to full trial.
6. Minimum duration of follow-up: Applicants to define and justify. Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means, such as routine data, as part of a separately funded study.

Rationale

Asthma is the most common chronic disease in children and young people (CYP) in the UK. Whilst many CYP are successfully able to manage their asthma on a day-to-day basis, some may experience asthma exacerbations, or attacks. These may have various causes, such as respiratory infections or airway irritants. During an asthma attack, the airways become swollen and inflamed. Inhaled bronchodilators and corticosteroids are used to try to relax the muscles and calm inflammation.

If this does not help, CYP will be experiencing severe acute asthma (SAA) and this can be life-threatening. As the airway is very narrow during SAA, drugs need to be given intravenously in order to be effective. There are 3 bronchodilators which can be given intravenously, however there is a lack of evidence around which one is most effective. Each drug has different side effects, and across Europe there is great variation in how they are used to treat SAA in CYP.

Optimising how SAA in CYP is managed will improve patients’ outcomes. Therefore, an adequately powered randomised controlled trial is required.

To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, NIHR strongly encourages the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of nurse, midwife and allied health professional-related research activity, capacity and capability across the professions. Depending on the level of experience, this could be through the role of lead applicant, as joint co-applicant supported by detailed mentoring plans submitted with the application, or as a co-applicant member of the research team. Through this activity, NIHR aims to support nurses, midwives and allied health professionals to become future research leaders and release the potential to lead, use, deliver and participate in research as a part of their job.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

Your application must be submitted online no later than 1pm on 20 September 2023. Applications will be considered by the HTA Funding Committee at its meeting in November.

HTA Programme Stage 1 guidance notes are available, alongside supporting information for applicants.

Please note that shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in March 2024.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application, for example a lead from a named charity or a unique national expert in a condition.

For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams. Both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact htagb@nihr.ac.uk.