Title: Development and evaluation of an online FeNO-guided primary care asthma management intervention
Funder: Department of Health and Social Care

Abstract: Research question Does implementation of an optimised FeNO-guided management intervention during routine primary care asthma reviews reduce acute exacerbations of asthma? Background Inhaled corticosteroids (ICS) are the cornerstone of treatment to reduce eosinophilic airway inflammation and prevent acute exacerbations. However, despite a 30% increase in spending on ICS treatment in England since 2007, annual asthma-related mortality, hospitalisation and exacerbation rates have not improved since 2000. Most monitoring of asthma occurs in primary care, where treatment decisions are based on symptoms and lung function. However, these measures do not reliably indicate eosinophilic airway inflammation or future exacerbation risk. Fractional exhaled nitric oxide (FeNO) is a simple, non-invasive breath test which is already extensively used to assess eosinophilic airway inflammation in UK hospital settings, but rarely in primary care. The National Institute for Health and Care Excellence (NICE) recognises the value of FeNO in diagnosis of asthma, but has highlighted the need for more robust evidence to guide its use in monitoring asthma treatment. Aims and objectives To iteratively develop and refine a complex online FeNO-guided asthma management intervention for use in primary care. To determine whether our intervention is more effective than usual care in reducing acute exacerbations of asthma. To assess the cost-effectiveness of our intervention. To investigate potential influences on implementation and outcomes of our intervention in primary care. Methods To develop and refine our intervention, we will conduct systematic theory, evidence and person-based intervention planning informed by consultation with stakeholders, qualitative interviews with health care professionals and patients, and small-scale implementation in general practices. We will then evaluate the effectiveness of our intervention by conducting a pragmatic parallel randomised controlled trial (RCT) in UK general practices. To optimise our recruitment strategy and procedures, we will perform a three-month internal pilot phase, proceeding to the main phase if pre-specified progression criteria are met. We will conduct an economic evaluation based on trial findings to determine whether our intervention is cost-effective and a mixed methods process evaluation of our intervention involving quantitative process outcomes and qualitative interviews with health care professionals and patients. Timelines for delivery We will produce our optimised intervention during the first 18 months of our programme and complete the internal pilot phase of our RCT by the end of year 2, progressing to the main phase in year 3. We will aim to complete recruitment by the end of year 3 and collection of follow-up data by the end of year 4. We will complete our analysis of RCT data, economic evaluation, and process evaluation by the end of year 5. Anticipated impact and dissemination Our findings will have strong potential to influence national guidelines and clinical practice within five years of this programme being completed. We will work with policymakers and guideline developers to incorporate our findings into BTS/SIGN and NICE guidance. We will also make our online intervention freely available to health care professionals and raise awareness of our intervention through scientific publications, conference presentations, educational workshops, and patient organisations including Asthma UK.

Lay abstract: Background: asthma remains a big problem 5.4 million people in the UK have asthma, which costs the NHS &pound;1.1 billion/year. 300 people/day are admitted to hospital and 3 people die daily. Most deaths and attacks could be prevented by better treatment. People can mostly control asthma by taking preventer inhalers every day to reduce inflammation and reliever inhalers as needed but for flare-ups (exacerbations), people may need steroid tablets, or even admission to hospital. Monitoring inflammation in asthma: using FeNO in general practice Asthma is caused by inflammation but how people feel does not always match how much inflammation is in their airways. Hospital clinics sometimes use a simple breath test called fractional exhaled nitric oxide (FeNO) to measure inflammation. This helps them ensure that patients are taking their inhalers properly and are on the right dose to prevent exacerbations. Measuring FeNO can also help show who can reduce treatment safely, potentially lessening side-effects, improving quality of life, and saving costs. 75% of asthma patients have an annual GP check-up. However, it is not clear yet whether FeNO measurement helps at these check-ups. At the moment, it's only done in people with severe asthma who attend a hospital clinic. It may be that using these tests more widely would cut asthma attacks and help decide when the inhaler doses need increasing or can be cut. NICE has asked for further research. Research plan: Our research will: -Produce an online training package for doctors and nurses in GP surgeries to help them use FeNO effectively -See if this package reduces exacerbations and improves quality of life. -Help policymakers make asthma services more efficient. We will work with asthma experts, GPs, nurses and patients. Professionals and patients at GP surgeries will try out our package and suggest improvements. We will do a research study involving over 2500 asthma patients from around 130 GP surgeries. Patient representatives will be involved at all stages, including helping to design study materials and information leaflets and making sure that the study is acceptable to patients. Working with the public and patients We have expertise in involving asthma patients and developing training packages for professionals. We are working with Asthma UK, who have helped us to plan the study and will raise awareness about our research. One of the members of our team is a patient with asthma who has contributed the patient perspective. We have also received valuable advice and support from our NIHR PPI advisor. We will go on to form a core group of 6 patient advisors who will be offered appropriate training and who will meet 3 times a year. We will invite 2 people with asthma to join the Trial Steering Committee.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY