Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-01

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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FeNO group

asthma patients, exhaled NO is used to monitor asthma

measurement of exhaled NO is used to guide treatment

Intervention Type DEVICE

exhaled NO

Symptom group

asthma patients, exhaled NO is not used to monitor asthma

No interventions assigned to this group

Interventions

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measurement of exhaled NO is used to guide treatment

exhaled NO

Intervention Type DEVICE

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No