AsthmaNCT00815984
Fractional Exhaled Nitric Oxide (FeNO) Result Prediction Factors in Children With Allergic Diseases
An observational study of Asthma and Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma, Allergic Rhinitis, Atopic Dermatitis
- What is being tested?
- measurements of lung function tests
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2009to Jan 2010
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis
Who may be able to join
- Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis
Who cannot join
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics and Allergy, N. Copernicus Hospital
Lodz, 93-513
About this study
Official title: FeNO Result Prediction Factors in Children With Allergic Diseases
In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.
Read the detailed description
In about 800 children with allergic diseases from our Outpatient Clinic (asthma, allergic rhinitis, atopic dermatitis) we will retrospectively and cross-sectionally analyse the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.
- Conditions
- Asthma, Allergic Rhinitis, Atopic Dermatitis
- Being tested
- measurements of lung function tests
- Keywords
- Asthma, Allergic Rhinitis, Atopic Dermatitis, Children, lung function, skin prick tests, FeNO
- Medical subject headings
- Asthma, Rhinitis, Allergic, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurements of lung function testsProcedure or surgery
Also called NO analyzer- Sievers 280i analyzer, Spirometry and Plethysmography - Jaeger, Exercise provocation test treadmill- Kettler
Measurement of the concentration of FeNO , measurement of spirometry, plethysmography, exercise challenge test (ECT -spirometric), bronchial obstruction reversibility pharmacological test
| Study group | Role | What they receive |
|---|---|---|
| Schoolchildren with asthma. | Schoolchildren with asthma. Receives: Procedure: measurements of lung function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of nitric oxide in exhaled breath.
Measured: 1-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Iwona Stelmach, MD PhD Prof, Study chair, Department of Pediatrics and Allergy, N. Copernicus Hospital, Lodz, PolandTomasz Grzelewski, MD, PhD, Principal investigator, Department of Pediatrics and Allergy, N. Copernicus Hospital, Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815984
- Sponsor's protocol ID
- RNN/135/08/KE
- Status last verified
- Feb 2010
- First submitted
- 30 Dec 2008
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Grzelewski T, Majak P, Jerzynska J, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Stelmach I. The interpretation of exhaled nitric oxide values in children with asthma depends on the degree of bronchoconstriction and the levels of asthma severity. Respir Care. 2014 Sep;59(9):1404-11. doi: 10.4187/respcare.02889. Epub 2013 Dec 31.
PubMed 24381190
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FeNO Result Prediction Factors in Children With Allergic Diseases
- ClinicalTrials.gov ID
- NCT00815984
- Acronym / sponsor ID
- RNN/135/08/KE
- Conditions
- Asthma, Allergic Rhinitis, Atopic Dermatitis
- Keywords
- Asthma, Allergic Rhinitis, Atopic Dermatitis, Children, lung function, skin prick tests, FeNO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Dec 2008 (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.
In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.
Detailed description
In about 800 children with allergic diseases from our Outpatient Clinic (asthma, allergic rhinitis, atopic dermatitis) we will retrospectively and cross-sectionally analyse the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schoolchildren with asthma. | – | Procedure: measurements of lung function testsSchoolchildren with asthma. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis
Key inclusion criteria (1 listed)
- Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis
Key exclusion criteria (3 listed)
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
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 |
|---|---|---|
| measurements of lung function testsAlso: NO analyzer- Sievers 280i analyzer, Spirometry and Plethysmography - Jaeger, Exercise provocation test treadmill- KettlerMeasurement of the concentration of FeNO , measurement of spirometry, plethysmography, exercise challenge test (ECT -spirometric), bronchial obstruction reversibility pharmacological test | Procedure or surgery | Schoolchildren with asthma. |
Primary outcome
Concentration of nitric oxide in exhaled breath.
Time frame: 1-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
- Derived from this study: PubMed 24381190Grzelewski T, Majak P, Jerzynska J, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Stelmach I. The interpretation of exhaled nitric oxide values in children with asthma depends on the degree of bronchoconstriction and the levels of asthma severity. Respir Care. 2014 Sep;59(9):1404-11. doi: 10.4187/respcare.02889. Epub 2013 Dec 31.
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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.
Iwona Stelmach, MD PhD Prof study chair
Department of Pediatrics and Allergy, N. Copernicus Hospital, Lodz, Poland
Tomasz Grzelewski, MD, PhD principal investigator
Department of Pediatrics and Allergy, N. Copernicus Hospital, Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, 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: finished, as of the sponsor's last update on 10 Feb 2010. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of nitric oxide in exhaled breath. (time frame: 1-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815984, which also lists 1 linked publication.
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 10 Feb 2010.