AsthmaPhase 4NCT00500253
Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
A Phase 4 study testing exhaled nitric oxide measurement, bronchial hyperresponsiveness with methacholine (PC20M) and symptom score diary (according to 2007 GINA guidelines) in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- exhaled nitric oxide measurement, bronchial hyperresponsiveness with methacholine (PC20M) and symptom score diary (according to 2007 GINA guidelines)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2007to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)
Who cannot join
- presence of other perennial and seasonal allergies
- presence of other chronic diseases
- excluded medications: systemic glucocorticosteroids 3 months before enrollment
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
Lodz, 93-513
Anna Sołoniewicz, MD, 00 48 42 6895972, alergol@kopernik.lodz.pl
Anna Sołoniewicz, MD
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- exhaled nitric oxide measurement, bronchial hyperresponsiveness with methacholine (PC20M), symptom score diary (according to 2007 GINA guidelines)
- Keywords
- exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhaled nitric oxide measurementDevice
Also called exhaled nitric oxide measurement (Sievers FeNO analyzer)
exhaled nitric oxide measurement
bronchial hyperresponsiveness with methacholine (PC20M)Procedure or surgery
Also called PC20M Jaeger APS system
bronchial hyperresponsiveness with methacholine (PC20M)
symptom score diary (according to 2007 GINA guidelines)Procedure or surgery
symptom score diary (according to 2007 GINA guidelines)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | children with asthma with FeNO monitored treatment (study group) Receives: Device: exhaled nitric oxide measurement; Procedure: bronchial hyperresponsiveness with methacholine (PC20M) |
| 2 | Other | group of children with treatment monitored by GINA's grade of disease clinical control (control group) Receives: Procedure: bronchial hyperresponsiveness with methacholine (PC20M); Procedure: symptom score diary (according to 2007 GINA guidelines) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of the disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Anna Sołoniewicz, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD, PhD, Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500253
- Sponsor's protocol ID
- RNN-56-07-KE
- Status last verified
- Feb 2013
- First submitted
- 11 Jul 2007
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
- ClinicalTrials.gov ID
- NCT00500253
- Acronym / sponsor ID
- RNN-56-07-KE
- Conditions
- Asthma
- Keywords
- exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: exhaled nitric oxide measurement, Procedure: bronchial hyperresponsiveness with methacholine (PC20M)children with asthma with FeNO monitored treatment (study group) |
| 2 | Other | Procedure: bronchial hyperresponsiveness with methacholine (PC20M), Procedure: symptom score diary (according to 2007 GINA guidelines)group of children with treatment monitored by GINA's grade of disease clinical control (control group) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)
Key exclusion criteria (3 listed)
- presence of other perennial and seasonal allergies
- presence of other chronic diseases
- excluded medications: systemic glucocorticosteroids 3 months before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exhaled nitric oxide measurementAlso: exhaled nitric oxide measurement (Sievers FeNO analyzer)exhaled nitric oxide measurement | Device | 1 |
| bronchial hyperresponsiveness with methacholine (PC20M)Also: PC20M Jaeger APS systembronchial hyperresponsiveness with methacholine (PC20M) | Procedure or surgery | 1, 2 |
| symptom score diary (according to 2007 GINA guidelines)symptom score diary (according to 2007 GINA guidelines) | Procedure or surgery | 2 |
Primary outcome
Control of the disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Sołoniewicz, MD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exhaled nitric oxide measurement, bronchial hyperresponsiveness with methacholine (PC20M) and symptom score diary (according to 2007 GINA guidelines) in people with Asthma, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Sołoniewicz, MD (00 48 42 6895972, alergol@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of the disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.