Condition category
Respiratory
Date applied
11/12/2006
Date assigned
31/07/2007
Last edited
16/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Graham Roberts

ORCID ID

Contact details

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

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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22747899

Publication citations

Additional files

Editorial Notes