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CompletedNCT00562991NOASTHMAUpdated Jan 28, 2021

Monitoring Asthma Treatment Using Exhaled Nitric Oxide

An observational study in Asthma, sponsored by University Hospital, Antwerp. Completed at 7 sites in Belgium. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
99
Ages
5 Years to 14 Years
Sex
All
01

Study 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.

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Conditions studied

  • Asthma

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Keywords

  • exhaled NO
  • asthma
  • child
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 99 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

asthmatic children

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
99 participants (actual)

Groups and cohorts

  • FeNO group

    asthma patients, exhaled NO is used to monitor asthma

    Device: measurement of exhaled NO is used to guide treatment

  • Symptom group

    asthma patients, exhaled NO is not used to monitor asthma

Interventions

  • Devicemeasurement of exhaled NO is used to guide treatment

    exhaled NO

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What researchers measure

Primary outcomes

  1. symptom-free days

    Time frame: 1 year time frame with visits every 3 months

Secondary outcomes

  1. days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations

    Time frame: 1 year time frame

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Study locations

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

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. PubMed 24039119 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00562991
Lead sponsor
University Hospital, Antwerp
Collaborators
Merck Sharp & Dohme LLC, Aerocrine AB
Responsible party
Sponsor
First posted
Nov 26, 2007
Start date
Oct 1, 2007
Primary completion
Oct 1, 2008
Completion
Dec 2009
Last update
Jan 28, 2021

Study contacts

kristine N Desager, PhD
principal investigator · University Hospital, Antwerp

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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