Monitoring Asthma Treatment Using Exhaled Nitric Oxide (NOASTHMA)
This study has been completed.
Sponsor:
University Hospital, Antwerp
Collaborators:
Merck
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
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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
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 June 17, 2013