Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4
Study information
Scientific title
Can monitoring exhaled nitric oxide levels in outpatients improve the management of children with asthma?
Acronym
Exhaled nitric oxide study
Study hypothesis
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
As per 09/02/2012, the anticipated end date has been updated from 31/08/2008 to 31/08/2009 and the target number of participants amended from 150 to 93.
Ethics approval
Southampton and Southwest Hampshire Local Research Ethics Committee, 18/05/2006, ref: 06/Q1702/9
Study design
Multicentre pragmatic prospective randomised double-blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma
Intervention
Current interventions as of 09/02/2012:
93 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.
Previous interventions:
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
12/12/2006
Overall trial end date
31/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
93
Participant exclusion criteria
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
Recruitment start date
12/12/2006
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton University Hospital NHS Trust
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
Research Governance
Legal Services
Building 37
Highfield Road
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Sport Aiding Medical Research for Kids (SPARKS) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22747899