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ISRCTN
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ISRCTN50872816
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ClinicalTrials.gov identifier
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Public title
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Can monitoring exhaled nitric oxide levels in outpatients improve the management of children with asthma?
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Scientific title
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Acronym
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Exhaled nitric oxide study
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Serial number at source
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4
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Study hypothesis
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The aim of this study is to explore whether monitoring exhaled Nitric Oxide (eNO) levels in outpatients improves the management of children with asthma using a pragmatic experimental design.
The specific objectives are:
1. To determine whether using eNO levels in outpatients to direct therapy allows less inhaled corticosteroid to be used over a year of follow when compared to a control group
2. To determine whether using eNO levels in outpatients to direct therapy reduces the number of exacerbations that require treatment with systemic corticosteroid over a year of follow when compared to a control group
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Ethics approval
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Southampton and Southwest Hampshire Local Research Ethics Committee approved on 18th May 2006 (ref: 06/Q1702/9).
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Study design
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A multicentre, pragmatic, prospective, randomised, double-blind, study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Asthma
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Participants - inclusion criteria
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1. Aged 6 - 17 years
2. Clinical diagnosis of asthma
3. Treatment with at least 400 mcg daily of beclomethasone/budesonide or 200 mcg daily of fluticasone
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Participants - exclusion criteria
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1. Inability to perform lung function or eNO measurement
2. Cigarette smoking
3. Poor compliance with medication
4. Previous life-threatening exacerbations
5. Need for maintenance oral prednisolone
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Anticipated start date
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12/12/2006
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Anticipated end date
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31/08/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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150 subjects aged 6 to 17 years with moderate or severe asthma will be recruited. Their asthma will be stabilised and they will be randomised to the exhaled nitric oxide (eNO) or control group.
All will be assessed every two months for a year. The control group will be managed according to the British Thoracic Society guidelines. In the eNO group, the inhaled corticosteroid doses will be increased in response to elevated eNO levels and reduced if levels are low. Subjects and medical staff involved in managing any exacerbations will be blind to group allocation.
An intention to treat analysis will be undertaken with a comparison of the change in inhaled corticosteroid dose and the number of exacerbations over the one-year follow up period between the two groups. It is expected that the eNO group will use less inhaled corticosteroids and experience less exacerbations.
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Primary outcome measure(s)
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An intention to treat analysis will be undertaken with a comparison of the change in inhaled steroid dose and the number of exacerbations over the one-year follow up period between the eNO and control groups.
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Secondary outcome measure(s)
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1. A per protocol analysis will be undertaken, the dataset for this analysis will be restricted to the subjects whose therapy was directed as per the protocol
2. Subgroup analysis restricted to subjects taking inhaled corticosteroid through a metered dose inhaler with a spacer as it is expected that these will form a more homogeneous analysis group
3. Subgroup analysis focusing firstly on subjects with moderate (400 - 800 mcg/day beclomethasone equivalent) and secondly subjects with severe (greater than 800 mcg/day beclomethasone equivalent) asthma to determine whether results are similar in both groups
4. Subgroup analysis focusing on firstly on atopic asthmatics and secondly non-atopic ones
5. Analyses restricted firstly to only viral associated exacerbations and secondly to exacerbations that are not associated with a viral infection
6. Comparison of the average inhaled steroid use in each group over the last six months of follow up
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Sources of funding
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Sport Aiding Medical Research for Kids (SPARKS) (UK)
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Trial website
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Publications
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Contact name
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Dr
Graham
Roberts
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Address
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Clinical Senior Lecturer/Consultant Paediatrician
University Child Health (MP803)
Level F South Academic Block
Southampton University Hospital NHS Trust
Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Sponsor
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University of Southampton (UK)
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Address
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Research Governance
Legal Services
Building 37
Highfield Road
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City/town
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Southampton
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Zip/Postcode
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SO17 1BJ
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Country
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United Kingdom
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Sponsor website:
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http://www.soton.ac.uk/
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Date applied
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11/12/2006
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Last edited
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31/07/2007
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Date ISRCTN assigned
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31/07/2007
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