Monitoring Asthma Treatment Using Exhaled Nitric Oxide (NOASTHMA)

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Aerocrine AB
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00562991
First received: November 21, 2007
Last updated: June 15, 2011
Last verified: November 2007

November 21, 2007
June 15, 2011
October 2007
Not Provided
symptom-free days [ Time Frame: 1 year time frame with visits every 3 months ] [ Designated as safety issue: No ]
symptom-free days [ Time Frame: prospective ]
Complete list of historical versions of study NCT00562991 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed [ Time Frame: prospective ]
Not Provided
Not Provided
 
Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Monitoring Asthma Treatment Using Exhaled Nitric Oxide

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

asthmatic children

Asthma
Device: measurement of exhaled NO is used to guide treatment
exhaled NO
  • FeNO group
    asthma patients, exhaled NO is used to monitor asthma
    Intervention: Device: measurement of exhaled NO is used to guide treatment
  • Symptom group
    asthma patients, exhaled NO is not used to monitor asthma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
December 2009
Not Provided

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
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00562991
B30020072436
No
Kristine N. Desager, University Hospital Antwerp
University Hospital, Antwerp
  • Merck Sharp & Dohme Corp.
  • Aerocrine AB
Principal Investigator: kristine N Desager, PhD University Hospital, Antwerp
University Hospital, Antwerp
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP