Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by Medical Universtity of Lodz.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical Universtity of Lodz
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00500253
First received: July 11, 2007
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in treatment monitoring in children with asthma.
According to the aim of the study following assumptions are formulated:
- Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
- Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
- Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Device: exhaled nitric oxide measurement Procedure: bronchial hyperresponsiveness with methacholine (PC20M) Procedure: symptom score diary (according to 2007 GINA guidelines) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma |
Resource links provided by NLM:
Further study details as provided by Medical Universtity of Lodz:
Primary Outcome Measures:
- Control of the disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
children with asthma with FeNO monitored treatment (study group)
|
Device: exhaled nitric oxide measurement
exhaled nitric oxide measurement
Other Name: exhaled nitric oxide measurement (Sievers FeNO analyzer)
Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
bronchial hyperresponsiveness with methacholine (PC20M)
Other Name: PC20M Jaeger APS system
|
|
2
group of children with treatment monitored by GINA's grade of disease clinical control (control group)
|
Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
bronchial hyperresponsiveness with methacholine (PC20M)
Other Name: PC20M Jaeger APS system
Procedure: symptom score diary (according to 2007 GINA guidelines)
symptom score diary (according to 2007 GINA guidelines)
|
Detailed Description:
Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on both children and adults.
What needs to be kept in mind, especially in assessing treatment effect of allergic inflammation in children with asthma, is that symptom score and spirometry measures have limitations, mainly their subjectivity (symptom scores), wide variability, and lack of stability in short time period (symptom scores and spirometry measures).
Monitoring allergic inflammation in the course of asthma in children with exhaled nitric oxide measurement (FeNO) may allow to titrate the dose of inhaled glucocorticosteroids more precisely, depending on individual patients requirements.
The aim of this study is to assess the utility of FeNO in treatment monitoring in children with asthma.
According to the aim of the study following assumptions are formulated:
- Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
- Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
- Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)
Exclusion Criteria:
- presence of other perennial and seasonal allergies
- presence of other chronic diseases
- excluded medications: systemic glucocorticosteroids 3 months before enrollment
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500253
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500253
Contacts
| Contact: Anna Sołoniewicz, MD | 00 48 42 6895972 | alergol@kopernik.lodz.pl |
Locations
| Poland | |
| Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland | Recruiting |
| Lodz, Poland, 93-513 | |
| Contact: Anna Sołoniewicz, MD 00 48 42 6895972 alergol@kopernik.lodz.pl | |
| Sub-Investigator: Anna Sołoniewicz, MD | |
| Principal Investigator: Iwona Stelmach, MD, PhD, Prof | |
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
| Principal Investigator: | Anna Sołoniewicz, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
| Study Chair: | Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
More Information
| Responsible Party: | Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz |
| ClinicalTrials.gov Identifier: | NCT00500253 History of Changes |
| Other Study ID Numbers: | RNN-56-07-KE |
| Study First Received: | July 11, 2007 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Medical Universtity of Lodz:
|
exhaled nitric oxide asthma children inhaled glucocorticosteroids |
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 Methacholine Chloride Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents Miotics Parasympathomimetics Bronchoconstrictor Agents Muscarinic Agonists Cholinergic Agonists |
ClinicalTrials.gov processed this record on September 29, 2016