Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Asthma Clinical Trial

— NOASTHMA  

Official title:

Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562991
• Other study ID #: B30020072436
• Status: Completed
• Start date: October 1, 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2007
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2009
• Est. primary completion date: October 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp
Belgium	Algemeen Ziekenhuis St Jan	Brugge
Belgium	Hôpital Erasme	Brussels
Belgium	Univ des enfants Reine Fabiola	Brussels
Belgium	Virga Jesseziekenhuis	Hasselt
Belgium	Algemeen ziekenhuis Turnhout, Campus Sint-Jozef	Turnhout
Belgium	CH Peltzer	Verviers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Aerocrine AB, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom-free days		1 year time frame with visits every 3 months
Secondary	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