Can monitoring exhaled nitric oxide levels in outpatients improve the management of children with asthma?
| ISRCTN | ISRCTN50872816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50872816 |
| Protocol serial number | 4 |
| Sponsor | University of Southampton (UK) |
| Funder | Sport Aiding Medical Research for Kids (SPARKS) (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre pragmatic prospective randomised double-blind study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
