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WELCOME TO RAACENO

Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy - a randomised trial

What is RAACENO?

RAACENO (pronounced "ra-chino") is a study that will investigate whether adding exhaled nitric oxide measurements to standard asthma care will help prevent asthma attacks in children. We all breathe out a gas called nitric oxide. We can measure exhaled nitric oxide 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. We know that these allergic cells build up before an asthma attack. We now want to see whether adding exhaled nitric oxide measurements to standard asthma care will help prevent asthma attacks in children.

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Can I take part?

We are recruiting patients at hospitals in the UK. You can see the location of these hospitals in the section of this website "where can I take part". Children and young people in the catchment area for these hospitals can take part if they

  • are aged 6-15 years,
  • have asthma,
  • are treated with inhaled corticosteroids,
  • have had an asthma attack treated with steroid tablets in the past year.

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If you are interested in taking part, or have any questions

Where can I take part?

Royal Aberdeen Children's Hospital

Key people:

Investigator:

  • Dr Steve Turner

Address:

NHS Grampian
Foresterhill
Westburn Road
Aberdeen
AB25 2ZG
Tayside Children's Hospital

Key people:

Investigator:

  • Dr Jonathan McCormack

Address:

NHS TAYSIDE
MACH 2 Building
Level 4, Ninewells
Dundee
DD1 9SY
Royal Hospital for Children

Key people:

Investigator:

  • Dr James Paton

Address:

NHS Greater Glasgow and Clyde
1345 Govan Road
Govan
Glasgow
G51 4TF
Leicester Children’s Hospital

Key people:

Investigator:

  • Dr Erol Gaillard

Address:

University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary
Leicester
LE1 5WW
Barnsley Hospital - coming soon

Key people:

Investigator:

  • Dr Diamuid Kerrin

Address:

Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
Sheffield Childrens Hospital

Key people:

Investigator:

  • Dr Sonal Kansra

Address:

Sheffield Childrens Hospital NHS Trust
Western Bank
Sheffield
S10 2TH
Royal Stoke University Hospital

Key people:

Investigator:

  • Dr Will Carroll

Address:

University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
Staffordshire
ST4 6QG
New Cross Hospital

Key people:

Investigator:

  • Dr Sally Edwards

Address:

THE ROYAL WOLVERHAMPTON NHS TRUST
Wolverhampton Road
Wolverhampton
WV10 0QP
University Hospital Crosshouse

Key people:

Investigator:

  • Dr Timothy Adams

Address:

NHS Ayrshire & Arran
Kilmarnock Rd
Kilmarnock
KA2 0BE
Royal Devon and Exeter Hospital

Key people:

Investigator:

  • Dr Patrick Oades

Address:

Royal Devon and Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
Derriford Hospital

Key people:

Investigator:

  • Dr Denise Ullmann

Address:

Plymouth Hospitals NHS Trust
Derriford Road
Crownhill
Plymouth
PL6 8DH
Birmingham Children's Hospital - coming soon

Key people:

Investigator:

  • Dr Priti Kenia

Address:

Birmingham Women’s and Children’s Hospital NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
Nottingham Children's Hospital - coming soon

Key people:

Investigator:

  • Dr Jayesh Bhatt

Address:

Nottingham University Hospitals NHS Trust
Queen's Medical Centre
Nottingham
NG7 2UH
Bradford Royal Infirmary

Key people:

Investigator:

  • Dr Anil Shenoy

Address:

Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
Bradford
BD9 6RJ
Southampton General Hospital - coming soon

Key people:

Investigator:

  • Prof Graham Roberts

Address:

University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
Royal Hospital for Sick Children - coming soon

Key people:

Investigator:

  • Dr Kenneth Macleod

Address:

NHS Lothian
Sciennes Road
Edinburgh
EH9 1LF
Royal Derby Hospital - coming soon

Key people:

Investigator:

  • Donna Traves

Address:

Derby Teaching Hospitals NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
Manor Hospital - coming soon

Key people:

Investigator:

  • Dr Hesham Abdalla

Address:

Walsall Healthcare NHS Trust
Moat Road
Walsall
WS2 9PS
Bristol Royal Hospital for Children - coming soon

Key people:

Investigator:

  • Dr Simon Langton-Hewar

Address:

University Hospitals Bristol NHS Foundation Trust
Upper Maudlin Street
Bristol
BS2 8AE
Leeds Children's Hospital - coming soon

Key people:

Investigator:

  • Dr Emma Guy

Address:

Leeds Teaching Hospitals West Yorkshire
Leeds Children's Hospital
Great George Street
Leeds Teaching Hospitals West Yorkshire
LS1 3EX
King’s College Hospital - coming soon

Key people:

Investigator:

  • Dr Atul Gupta

Address:

Denmark Hill
London
SE5 9RS
- coming soon

Key people:

Investigator:

  • Dr Chinedu Nwokoro

Address:

- coming soon

Key people:

Investigator:

Address:

- coming soon

Key people:

Investigator:

Address:

- coming soon

Key people:

Investigator:

Address:

- coming soon

Key people:

Investigator:

Address:

- coming soon

Key people:

Investigator:

Address:

- coming soon

Key people:

Investigator:

Address:

Study news

Recruitment

34/502

Trial sites

Latest addition to sites:

Bradford Royal Infirmary
Derriford Hospital
Royal Devon and Exeter Hospital
University Hospital Crosshouse

Key facts about the study and documents

Key facts about the study and documents

We all have a gas called nitric oxide in the air we breathe out. People of all ages with asthma have more nitric oxide in their breath than people without asthma. Nitric oxide levels go up before and during an asthma attack and come back down after an attack. We can measure nitric oxide levels in breathed out air. In this study, we will investigate whether adding nitric oxide measurements to standard care for children with asthma can help reduce asthma attacks.

We will recruit 502 children aged 6-15 years with a diagnosis of asthma, who currently use inhaled corticosteroids, and who have had an asthma exacerbation in the previous 12 months.


We will randomise children to either:

  • A group that will have their asthma treatment guided by symptoms alone. This is standard care for children with asthma, where the doctor or nurse asks about how the child’s asthma has been, about any coughing or wheezing and how often they use their inhaler. At the first visit, based on this information, the child’s asthma treatment may stay the same or may be changed slightly. Children will be followed up at 3, 6, 9 and 12 months. At each visit, the doctor or nurse will ask about the child’s asthma symptoms, and their asthma treatment may stay the same or be changed slightly.
  • A group that will have their asthma treatment guided by nitric oxide levels plus symptoms. The doctor or nurse will ask about how the child’s asthma has been, about any coughing or wheezing and how often they use their inhaler. The doctor or nurse will also measure how much nitric oxide the child breathes out. At the first visit, based on this information, the child’s asthma treatment may stay the same or may be changed slightly. Children will be followed up at 3, 6, 9 and 12 months. At each visit, the doctor or nurse will ask about the child’s asthma symptoms and measure their levels of breathed out nitric oxide. Based on this, their asthma treatment may stay the same or be changed slightly.

All children taking part will have a meter on their inhaled steroid inhaler. This will allow the research team to know how much of the inhaler is being taken.

The primary outcome is asthma exacerbation (attack) which will be assessed at the 3, 6, 9 and 12 month follow-up visits, and confirmed with data held in medical records. Secondary outcomes include time to first exacerbation, number of exacerbations, and quality of life.

The study 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 200 children will also be invited to take part in optional mechanistic studies alongside the main study. The optional mechanistic studies involve:

  1. spirometry after children have used their inhaler,
  2. collection of sputum (coughed up spit) to count a type of white blood cell (eosinophil);
  3. a skin prick test to determine reactivity (allergy) to common allergens; and
  4. saliva collected for future DNA analysis.


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.

Key contacts

Click on cards to find out more

Key questions & answers

Click on questions to find out more

What is the purpose of the study?

To see if asthma attacks can be reduced in children by measuring exhaled nitric oxide and using these measurements to help guide asthma treatment.

What is nitric oxide?

Nitric oxide is a gas that we all have in our breath and people with asthma breathe out more nitric oxide than people without asthma. Nitric oxide does several jobs in our bodies including controlling the blood flow through blood vessels and helping our brains remember things. In addition to being a helpful thing, it is also produced by allergic cells rather like a car produces fumes. Nitric oxide does not smell, and we can't see it, but we can measure it.

What do you expect to find?

Our work leading up to this study suggests that using exhaled nitric oxide levels to help guide asthma treatment might reduce asthma attacks in children with asthma. We are doing this study to find out whether this is the case or not.

Who can take part?

We will be asking children and young persons aged between 6 and 15 years to take part. They also need to be under the care of a hospital doctor for their asthma, to be on inhaled preventer medicine (called inhaled corticosteroids) and to have had an asthma attack treated with steroid tablets in the past year. We will be recruiting children in approximately 25 hospitals around the UK.

How long will the study last?

Children and young people taking part will be in the study for 12 months. The whole study will last 4 years.

How might this change asthma care?

If we find that asthma attacks are reduced with the help of the nitric oxide measurements we will recommend that all children with a recent asthma attack have nitric oxide testing.

What next?

This all depends on what we find in this study. If we find that asthma attacks are reduced by using nitric oxide measurements to help guide treatment, we will do a similar study in children and young people in general practices to see if nitric oxide can reduce asthma attacks there too.

Organisation

This study was funded by the Efficacy and Mechanism Evaluation (EME) Programme of the National Institute for Health Research (NIHR). Please visit the NIHR website for more information: www.nihr.ac.uk.