Monitoring Asthma Treatment Using Exhaled Nitric Oxide (NOASTHMA)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: measurement of exhaled NO is used to guide treatment

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • University Hospital Antwerp
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis St Jan
  • Brussels, Belgium
    • Hopital Erasme
  • Brussels, Belgium, 1020
    • Univ des enfants Reine Fabiola
  • Hasselt, Belgium, 3500
    • Virga Jesseziekenhuis
  • Turnhout, Belgium
    • Algemeen ziekenhuis Turnhout, Campus Sint-Jozef
  • Verviers, Belgium, 4800
    • CH Peltzer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

asthmatic children

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FeNO group; asthma patients, exhaled NO is used to monitor asthma	Device: measurement of exhaled NO is used to guide treatment; exhaled NO
Symptom group; asthma patients, exhaled NO is not used to monitor asthma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Merck Sharp & Dohme LLC; Aerocrine AB
• Investigators: Principal Investigator: kristine N Desager, PhD, University Hospital, Antwerp

Publications and helpful links

General Publications

• Peirsman EJ, Carvelli TJ, Hage PY, Hanssens LS, Pattyn L, Raes MM, Sauer KA, Vermeulen F, Desager KN. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul;49(7):624-31. doi: 10.1002/ppul.22873. Epub 2013 Sep 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 23, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: asthma; child; exhaled NO
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: B30020072436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No