Extrait

Background and study aims Asthma is a long-term condition which affects the airways. When a person is suffering from asthma, the airways are extremely sensitive (hyperresponsive) to both natural chemicals the body produces and irritants outside the body, such as dust or pollen. Coming into contact with these substances can cause an asthma attack (also known as an exacerbation), which involves feelings of tightness in the chest as the airways become inflamed (swollen), causing coughing, wheezing, chest tightness and difficulty breathing. Every year in the UK, 150,000 children see their family doctor for an asthma exacerbation and 25,000 are hospitalised. One third of the £1 billion NHS budget for asthma is spent on provision for unscheduled care of which about one half is for childhood exacerbations. Exacerbations are relatively infrequent and short-lived but their importance to patients is emphasised in the Global Initiative for Asthma whose major goals include “to prevent asthma exacerbations”. Everyone breathes out a gas called nitric oxide. Exhaled nitric oxide can be measured using a special breathing device. People with asthma breathe out more nitric oxide than people without asthma because nitric oxide is produced by the allergic cells which are present in the lungs of people with asthma. These allergic cells build up before an asthma attack. The aim of this study is to find out whether measuring fractional exhaled nitric oxide (FeNO) can guide asthma treatment and help prevent asthma attacks. Who can participate? Children aged between 6 and 16 who have been diagnosed with asthma and are currently being treated with inhaled steroids and who have had an asthma attack treated with steroid tablets. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group have their asthma treatment guided by symptoms and breath tests to measure FeNO. Those in the second group are treated according to the symptoms they are having alone. Participants in both groups are followed up after three, six, nine and twelve months in order to find out how many asthma exacerbations they have had and assessments of their quality of life. Participants are also offered additional allergy testing, which involves a blood test and a coughing up spit test. Additionally around 20 children are invited to take part in an interview at the end of the twelve month follow-up to explore attitudes to, and acceptability of the FeNO measurements. Five research nurses are also interviewed about the practicality of FeNO measurements. What are the possible benefits and risks of participating? All children will benefit from regular asthma assessments as part of the study. Asthma treatment is currently only guided by symptoms, and so children in the group where asthma treatment is guided by symptoms will continue to get current best asthma treatment. There is a risk that the optional allergy testing will cause itchiness on the participant’s arm for a short time. The optional coughing up spit test may make the participant cough and possibly also wheeze, but this will only be conducted following a lung function check. Where is the study run from? 25 hospitals around the UK When is the study starting and how long is it expected to run for? February 2017 to January 2021 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Dr Stephen Turner (scientific) [email protected] 2. Mrs Jess Wood (public) [email protected]

Critère d'inclusion

• Specialty: Children, Primary sub-specialty: Respiratory and Cystic Fibrosis; UKCRC code/ Disease: Respiratory/ Other diseases of the respiratory system

Liens

• isrctn