Can monitoring exhaled nitric oxide levels in outpatients improve the management of children with asthma?

ISRCTN	ISRCTN50872816
DOI	https://doi.org/10.1186/ISRCTN50872816
Secondary identifying numbers	4

Submission date: 11/12/2006
Registration date: 31/07/2007
Last edited: 16/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Graham Roberts
Scientific

Professor/Consultant Paediatrician
University Child Health (MP803)
Level F South Academic Block
Southampton University Hospital NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Study design	Multicentre pragmatic prospective randomised double-blind study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Can monitoring exhaled nitric oxide levels in outpatients improve the management of children with asthma?
Study acronym	Exhaled nitric oxide study
Study objectives	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(s)	Southampton and Southwest Hampshire Local Research Ethics Committee, 18/05/2006, ref: 06/Q1702/9
Health condition(s) or problem(s) studied	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
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 study start date	12/12/2006
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	17 Years
Sex	Both
Target number of participants	93
Key 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
Key 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
Date of first enrolment	12/12/2006
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southampton University Hospital NHS Trust

Southampton
SO16 6YD
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

Research Governance
Legal Services
Building 37
Highfield Road
Southampton
SO17 1BJ
England
United Kingdom

Website	http://www.soton.ac.uk/
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Charity

Sport Aiding Medical Research for Kids (SPARKS) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No