Monitoring Asthma Treatment Using Exhaled Nitric Oxide (NOASTHMA)

Antwerp University Hospital (UZA)

Status

Completed

Conditions

Asthma

Treatments

Device: measurement of exhaled NO is used to guide treatment

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT00562991

B30020072436

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

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