RAACENO Reducing Asthma Attacks in Children using Exhaled Nitric Oxide
Research type
Research Study
Full title
Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy - a randomised trial (RAACENO)
IRAS ID
212541
Contact name
Steve Turner
Contact email
Sponsor organisation
University of Aberdeen
ISRCTN Number
ISRCTN67875351
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Research Summary
Using Fractional exhaled Nitric Oxide (FeNO) measurements in breathed-out air may improve asthma control. In this study we will investigate this in children with asthma. We will recruit children aged 6-16 years with a diagnosis of asthma, who currently use of inhaled corticosteroids, and who have had an asthma exacerbation in the previous 12 months.
502 children will be randomised to (i) asthma treatment guided by FeNO measurements plus symptoms, or (ii) asthma treatment guided by symptoms alone (standard care). Participants will be followed up at 3, 6, 9 and 12 months. At each visit, their asthma symptoms, plus FeNO measurements in group (i) will be used to determine whether their asthma treatment should be changed or not.
The primary outcome is asthma exacerbation (attack) which will be assessed at 3, 6, 9 and 12 months post-randomisation, and confirmed with data held in medical records. Secondary outcomes include time to first exacerbation, number of exacerbations, and Quality of Life. The trial includes a health economic evaluation; data will be collected on asthma-related health care use, and time off school and away from other activities.
Around 20 children will be invited to take part in an interview at the end of the 12 month follow-up to explore attitudes to, and acceptability of the FeNO measurements. Five research nurses will also be interviewed about the feasibility of FeNO measurements.
Children will also be invited to take part in concurrent mechanistic studies (we anticipate that ~200 children randomised in the main trial will agree to take part in these). The mechanistic studies involve: (i) spirometry after children have used their inhaler, (ii) sputum collected to count a type of white blood cell (eosinophil); (iii) a skin prick test to determine reactivity to common allergens; and (iv) saliva collected for future DNA analysis.
Summary of Results
We wanted to find out whether or not a simple breath test (to measure how much nitric oxide is breathed out) might help doctors to decide the best treatment for children with asthma. Better treatment might reduce the chance of children having an asthma attack.In total, 509 children aged 6–15 years took part in the study. They either had their asthma treatment guided by their symptoms in the usual way or had their asthma treatment guided by their asthma symptoms plus their nitric oxide result. Information about symptoms and nitric oxide was entered into a computer system that made a recommendation about treatment (to keep treatment the same, or to increase or decrease the treatment). The doctors could follow this recommendation or make a different decision about treatment. Children were in the study for 12 months and had a treatment recommendation when they joined the study and then every 3 months. While they were in the study, we collected information about any asthma attacks that they had. The average age of the children in the study was 10 years and 60% were boys.
There was no difference in the proportion of children who had an asthma attack when comparing those who had their asthma treatment guided by symptoms alone with those who had their asthma treatment guided by symptoms plus their nitric oxide result. We looked at several other asthma outcomes (e.g. asthma symptoms, emergency visits and breathing tests) and none of these was different between treatment groups.
This means that adding the breath test to measure nitric oxide did not help doctors to decide the best treatment for children with asthma.
We interviewed some families and staff involved in the RAACENO (Reducing Asthma Attacks in Children using Exhaled Nitric Oxide) trial. They told us that taking part in RAACENO was a positive experience and that having treatment guided by a breath test and computer was broadly acceptable.
REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0106
Date of REC Opinion
4 Oct 2016
REC opinion
Favourable Opinion