Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Completed

• Conditions: Asthma
• Interventions: Device: measurement of exhaled NO is used to guide treatment

• Registration Number: NCT00562991
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-01
• Status Verified: 2007-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Study First Posted: 2007-11-26
• Primary Completion: 2008-10-01
• Study Completion: 2009-12
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FeNO group	measurement of exhaled NO is used to guide treatment	asthma patients, exhaled NO is used to monitor asthma

Primary Outcome Measures

Name	Time	Method
symptom-free days	1 year time frame with visits every 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Univ des enfants Reine Fabiola; 🇧🇪 Brussels, Belgium

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

Algemeen Ziekenhuis St Jan; 🇧🇪 Brugge, Belgium

Virga Jesseziekenhuis; 🇧🇪 Hasselt, Belgium

Hôpital Erasme; 🇧🇪 Brussels, Belgium

CH Peltzer; 🇧🇪 Verviers, Belgium

Algemeen ziekenhuis Turnhout, Campus Sint-Jozef; 🇧🇪 Turnhout, Belgium