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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50872816

Enrollment

Registered

2007-07-31

Start date

2006-12-12

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

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 nitri

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026