AsthmaNCT01805635
PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
An observational study of Asthma and Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis, Atopic Dermatitis
- How many people
- 5,500 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2013to Apr 2014
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: Children with allergic diseases, healthy children.
Who may be able to join
- Children with allergic diseases, healthy children.
Who cannot join
- Other serious diseases.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital
Lodz, 93-513
Iwona Stelmach, MDPhDProf, 48426895972, alergol@kopernik.lodz.pl
Tomasz Grzelewski, MDPhD, 48426895972, alergol@kopernik.lodz.pl
About this study
Official title: Evaluation of the Relationship Between the Parameters of Pulmonary Function (PF) and the Concentration of Fractional Exhaled Nitric Oxide (FeNO) and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases.
Read the detailed description
The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide (FeNO) level in children suspected and being diagnosed due to allergic diseases.
Study will be retrospective, conducted in all children diagnosed in the years of 2005-20012 in Laboratory of lung function tests of Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland. The investigators will analyse 5500 male an female children 5-18 year old suspected and being diagnosed due to allergic diseases. In these children nearly 3000 FeNO measurements, 65000 spirometry measurements, 22000 whole-body plethysmography measurements and 48000 occlusion resistance measurements were performed between the years of 2005-2012.
The investigators will retrospectively evaluate following data from medical documentation of patients:
- FeNO levels.
- Allergic disease diagnosis.
- Immunoglobulin E (IgE) specific levels.
- Treatment (drugs and dosages).
- Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).
- Conditions
- Asthma, Allergic Rhinitis, Atopic Dermatitis, Urticaria, Healthy
- Being tested
- No intervention
- Keywords
- Children, Asthma, Allergic rhinitis, Atopic dermatitis, Urticaria, Healthy
- Medical subject headings
- Asthma, Rhinitis, Allergic, Dermatitis, Atopic, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Children suspected of allergic diseases | Children suspected of allergic diseases No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic disease diagnosis
Allergic disease diagnosis. The diagnosis and the severity of asthma, allergic rhinitis and atopic dermatitis and other allergic diseases universally established by the doctors (allergologists) according to standard definitions of diseases in the latest guidelines
Measured: 7 years
Secondary outcomes (1)
Lung function (LF)
spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 5,500 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
- Iwona Stelmach, MDPhDProf, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, PolandTomasz Grzelewski, MDPhD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805635
- Sponsor's protocol ID
- RNN/23/13/KE
- Status last verified
- Sep 2013
- First submitted
- 25 Feb 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grzelewski T, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Majak P, Stelmach I. Spirometry-Adjusted Fraction of Exhaled Nitric Oxide Allows Asthma Diagnosis in Children, Adolescents, and Young Adults. Respir Care. 2016 Feb;61(2):162-72. doi: 10.4187/respcare.04092. Epub 2015 Dec 1.
PubMed 26628565Jerzynska J, Janas A, Galica K, Stelmach W, Woicka-Kolejwa K, Stelmach I. Total specific airway resistance vs spirometry in asthma evaluation in children in a large real-life population. Ann Allergy Asthma Immunol. 2015 Oct;115(4):272-6. doi: 10.1016/j.anai.2015.07.002. Epub 2015 Jul 26.
PubMed 26216360Grzelewski T, Witkowski K, Makandjou-Ola E, Grzelewska A, Majak P, Jerzynska J, Janas A, Stelmach R, Stelmach W, Stelmach I. Diagnostic value of lung function parameters and FeNO for asthma in schoolchildren in large, real-life population. Pediatr Pulmonol. 2014 Jul;49(7):632-40. doi: 10.1002/ppul.22888. Epub 2013 Sep 9.
PubMed 24019244
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between the Parameters of Pulmonary Function (PF) and the Concentration of Fractional Exhaled Nitric Oxide (FeNO) and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
- ClinicalTrials.gov ID
- NCT01805635
- Acronym / sponsor ID
- RNN/23/13/KE
- Conditions
- Asthma, Allergic Rhinitis, Atopic Dermatitis, Urticaria, Healthy
- Keywords
- Children, Asthma, Allergic rhinitis, Atopic dermatitis, Urticaria, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 6 Mar 2013 (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 influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide level in children suspected and being diagnosed due to allergic diseases.
Detailed description
The aim of this study is to assess the influence of kind of allergic disease, allergic profile, allergen exposure, treatment method on lung function parameters, fractional exhaled nitric oxide (FeNO) level in children suspected and being diagnosed due to allergic diseases.
Study will be retrospective, conducted in all children diagnosed in the years of 2005-20012 in Laboratory of lung function tests of Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland. The investigators will analyse 5500 male an female children 5-18 year old suspected and being diagnosed due to allergic diseases. In these children nearly 3000 FeNO measurements, 65000 spirometry measurements, 22000 whole-body plethysmography measurements and 48000 occlusion resistance measurements were performed between the years of 2005-2012.
The investigators will retrospectively evaluate following data from medical documentation of patients:
- FeNO levels.
- Allergic disease diagnosis.
- Immunoglobulin E (IgE) specific levels.
- Treatment (drugs and dosages).
- Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children suspected of allergic diseases | – | Other: No interventionChildren suspected of allergic diseases No intervention |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with allergic diseases, healthy children.
Key inclusion criteria (1 listed)
- Children with allergic diseases, healthy children.
Key exclusion criteria (1 listed)
- Other serious diseases.
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 |
|---|---|---|
| No interventionNo intervention | Other | Children suspected of allergic diseases |
Primary outcome
Allergic disease diagnosis
Time frame: 7 years
Allergic disease diagnosis. The diagnosis and the severity of asthma, allergic rhinitis and atopic dermatitis and other allergic diseases universally established by the doctors (allergologists) according to standard definitions of diseases in the latest guidelines
1 secondary outcome
Lung function (LF)
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Derived from this study: PubMed 26628565Grzelewski T, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Majak P, Stelmach I. Spirometry-Adjusted Fraction of Exhaled Nitric Oxide Allows Asthma Diagnosis in Children, Adolescents, and Young Adults. Respir Care. 2016 Feb;61(2):162-72. doi: 10.4187/respcare.04092. Epub 2015 Dec 1.
- Derived from this study: PubMed 26216360Jerzynska J, Janas A, Galica K, Stelmach W, Woicka-Kolejwa K, Stelmach I. Total specific airway resistance vs spirometry in asthma evaluation in children in a large real-life population. Ann Allergy Asthma Immunol. 2015 Oct;115(4):272-6. doi: 10.1016/j.anai.2015.07.002. Epub 2015 Jul 26.
- Derived from this study: PubMed 24019244Grzelewski T, Witkowski K, Makandjou-Ola E, Grzelewska A, Majak P, Jerzynska J, Janas A, Stelmach R, Stelmach W, Stelmach I. Diagnostic value of lung function parameters and FeNO for asthma in schoolchildren in large, real-life population. Pediatr Pulmonol. 2014 Jul;49(7):632-40. doi: 10.1002/ppul.22888. Epub 2013 Sep 9.
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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, MDPhDProf study chair
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Tomasz Grzelewski, MDPhD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, 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 1 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 9 Sep 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.
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 Iwona Stelmach, MDPhDProf (48426895972, alergol@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergic disease diagnosis (time frame: 7 years). 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 NCT01805635, which also lists 3 linked publications.
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 9 Sep 2013.