Every 2–3 minutes, a child in the UK has an asthma attack, costing the NHS £2 million per week and affecting 1.1 million children. Current guidelines recommend using spirometry—a simple breathing test—alongside symptoms to guide asthma treatment, but they do not specify how changes in spirometry results should alter medication. This leaves doctors without clear rules, and most do not use spirometry routinely. This trial will test whether adding spirometry to symptom-based treatment reduces asthma attacks in 550 children aged 6–15 who have had an attack in the past year. Half will receive treatment guided by symptoms alone; the other half will follow an algorithm that also incorporates spirometry results. The researchers will track the number of attacks over 12 months and explore the biological link between lung function, airway inflammation, and attack risk. If successful, the approach could give clinicians a concrete, evidence-based tool to adjust preventer medication before symptoms worsen—potentially preventing attacks, reducing hospital visits, and saving the NHS millions. The findings will also inform national asthma guidelines, shifting practice from reactive treatment to proactive, measurement-driven care.
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Background. There are 1.1 million UK children with asthma. One child has an asthma attack each 2-3 minutes in the UK. 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 change 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 approximately 57 sites. Our existing network already includes 42 sites prepared 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. Participant recruitment starts in month 7. Our internal pilot will assess recruitment progress in month 15. Follow up will end in month 42. The monograph will be submitted in month 48. 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.
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