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
  Purpose

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.


Condition Intervention
Asthma
Device: measurement of exhaled NO is used to guide treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • symptom-free days [ Time Frame: 1 year time frame with visits every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: October 2007
Study Completion Date: December 2009
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

asthmatic children

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562991

Locations
Belgium
University Hospital Antwerp
Antwerp, Belgium, 2650
Algemeen Ziekenhuis St Jan
Brugge, Belgium, 8000
Univ des enfants Reine Fabiola
Brussels, Belgium, 1020
Hôpital Erasme
Brussels, Belgium
Virga Jesseziekenhuis
Hasselt, Belgium, 3500
Algemeen ziekenhuis Turnhout, Campus Sint-Jozef
Turnhout, Belgium
CH Peltzer
Verviers, Belgium, 4800
Sponsors and Collaborators
University Hospital, Antwerp
Merck Sharp & Dohme Corp.
Aerocrine AB
Investigators
Principal Investigator: kristine N Desager, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Kristine N. Desager, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00562991     History of Changes
Other Study ID Numbers: B30020072436
Study First Received: November 21, 2007
Last Updated: June 15, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Antwerp:
exhaled NO
asthma
child

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014