Towards better asthma control in children:is there a role for the asthma control test and exhaled nitric oxide?

Towards better asthma control in children:is there a role for the asthma control test and exhaled nitric oxide? - Better Asthma Treatment: Monitoring with ACT and Nitric oxide.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37105

Enrollment

300

Registered

2009-07-16

Start date

2010-02-02

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

asthma

Interventions

In this study proposal 2 interventions will be compared to usual care. (1) Web group: an Internet program with monthly ACTs guides treatment - if ACT = 20: step down or no change (decided by treatin

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Childern 4-18 years old with atopic asthma, using inhaled corticosteroids for at least 3 months preceding the study. Children and/ or their parents should have access to the Internet at home. Children should be able to perform FENO measurements.

Exclusion criteria

Exclusion criteria: Exclusion criteria are active smoking, chronic lung disease other than asthma, recent (11 years) to read or understand Dutch.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the proportion of symptom free days during the last 4 weeks of the study. Power of the study is such that, with 87 children per group, an increase of the percentage of symptom free days of 18% (corresponding to 2.5 extra symptom free days per 2 weeks) as compared to the control group can be detected (power 80%, alpha=0.025). Taking into account some drop outs, we will include 100 patients per group. Primary endpoint of the pilot study is the post-dexamethasone cortisol levels.	—

Measure

Time frame

Primary endpoint is the proportion of symptom free days during the last 4 weeks of the study. Power of the study is such that, with 87 children per group, an increase of the percentage of symptom free days of 18% (corresponding to 2.5 extra symptom free days per 2 weeks) as compared to the control group can be detected (power 80%, alpha=0.025). Taking into account some drop outs, we will include 100 patients per group. Primary endpoint of the pilot study is the post-dexamethasone cortisol levels.

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Secondary

Measure	Time frame
Secondary endpoints are: costs, patient utilities, asthma related quality of life, symptoms, use of rescue and controller medication, bronchial hyperresponsiveness, FENO, lung function, exacerbations, ICS dose. Differences in societal costs will be compared to differences in the number of limited activity days (CEA) and in quality adjusted life years (CUA). Secondary endpoints of the pilot study: basal salivary cortisol levels.	—

Measure

Time frame

Secondary endpoints are: costs, patient utilities, asthma related quality of life, symptoms, use of rescue and controller medication, bronchial hyperresponsiveness, FENO, lung function, exacerbations, ICS dose. Differences in societal costs will be compared to differences in the number of limited activity days (CEA) and in quality adjusted life years (CUA). Secondary endpoints of the pilot study: basal salivary cortisol levels.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)