Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Study Overview
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Brief Summary
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Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.

Official Title
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Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Conditions
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Asthma

Intervention / Treatment
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* Device: measurement of exhaled NO is used to guide treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female children, aged 6-14 years A documented history of asthma for a period of at least 6 months Mild to severe persistent asthma according to GINA guidelines A documented history of allergic sensitization (positive skin prick test or specific IgE Subject's guardian/parent should be able to complete a symptom score on behalf of the subject. Subject's guardian/parent should be able to send a symptom score weekly by sms Both parents have to give written informed consent to participate in the study Exclusion Criteria: Received any investigational study medication in the 4 weeks prior to screening Visit Significant comorbidity such as concurrent infection, history of prematurity, history of bronchopulmonary dysplasia, cystic fibrosis, other chronic lung diseases, and other severe chronic diseases Acute asthma exacerbation within 4 weeks of screening visit Hospitalization within 12 weeks of screening visit Systemic corticosteroids within 12 weeks of screening visit Oral corticosteroid dependence

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FeNO group<br>asthma patients, exhaled NO is used to monitor asthma | Device: measurement of exhaled NO is used to guide treatment<br>* exhaled NO<br>|
| Symptom group<br>asthma patients, exhaled NO is not used to monitor asthma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom-free days |  | 1 year time frame with visits every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations |  | 1 year time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exhaled NO, asthma, child