Project: SPIROMAC

SPIROMAC: SPIROmetry to Manage Asthma in Children

Spirometry is a breathing test often done as part of ongoing asthma care. This study will compare whether the addition of spirometry to usual asthma care reduces asthma attacks in children.

Background

There are 1.1 million UK children with asthma. A child has an asthma attack each 2-3 minutes. Asthma attacks cause morbidity and occasionally mortality, and cost the NHS £2 million per week. Asthma attack risk is reduced by taking asthma preventer treatment. Some guidelines say spirometry should be used alongside symptoms to objectively guide prescribing preventer treatment, but do not say how change in spirometry should guide treatment change. Spirometry can be reproducibly measured in children aged over 5 years. Our research has shown how a fall in spirometry, even within “normal” limits and with controlled asthma symptoms, predicts risk of a future asthma attack in asymptomatic children. We have also shown that some UK doctors looking after children with asthma use spirometry routinely, but most do not.

Research questions

In children with asthma does spirometry and symptom guided treatment, compared to symptom guided treatment alone, reduce the number of asthma attacks? What is the mechanistic relationship between treatment guided by spirometry and the risk for an asthma attack?

Aims

To evaluate the efficacy of asthma treatment guided by spirometry plus symptoms, compared to symptoms alone, on asthma attacks in 550 children.

Objectives

1. To recruit children aged 6-15 years with asthma who have had an asthma attack in the last year.
2. At the baseline assessment, to take consent and collect demographic and asthma-related data.
3. To randomise participants to receive treatment guided by symptoms alone (control arm) or spirometry plus symptoms (intervention arm).
4. To use an algorithm to guide treatment decisions based on a validated symptom score, current treatment, treatment adherence and, in half the children, spirometry.
5. For all children to have spirometry measured on every visit.
6. To re-apply the algorithm at 3-month intervals over a year and adjust treatment where indicated by symptoms and, in half the children, spirometry plus symptoms.
7. To determine primary and secondary outcomes over the 12 months post randomisation. The primary outcome is number of asthma attacks. Secondary outcomes include any attack (yes/no) and time to first attack.
8. To understand the mechanistic relationship between treatment guided by spirometry, lung function and eosinophilic airway inflammation and the risk for an asthma attack.

Methods

A randomised controlled trial with mechanistic component. We will recruit from 57 sites. Our existing network already includes 42 sites prepared to recruit participants to SPIROMAC. We know from our previous trial (RAACENO) that these centres can recruit and already have lists of eligible participants. We will modify a computer-based algorithm, whose use proved feasible and acceptable in RAACENO. Analysis will be by intention to treat. Negative binomial regression will be used to compare the primary outcome between trial arms.

Timelines

The trial started in October 2021 and recruitment will start in August 2022.  In December 2022 our internal pilot will assess recruitment progress. Follow-up will end January 2025.  The monograph will be submitted in July 2025. 

Impact and dissemination

Our intervention could reduce asthma attacks and will give insight into the relationship between spirometry and attacks. Dissemination will include a summary to participants, publications in peer-reviewed journals, a report to funder and to asthma guideline committees.

Key people

The SPIROMAC team (left to right): Karen Innes, Andrea Fraser, Victoria Bell, Steve Turner, Seonaidh Cotton

Project website

Find out more on the SPIROMAC website

Contact us

Email the project team

Funding

This project (NIHR 129819) is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. The project is run by the University of Aberdeen and NHS Grampian.