PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
September 6, 2013 updated by: Iwona Stelmach, Medical University of Lodz
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
5500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lodz, Poland, 93-513
- Recruiting
- Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital
-
Contact:
- Iwona Stelmach, MDPhDProf
- Phone Number: 48426895972
- Email: alergol@kopernik.lodz.pl
-
Contact:
- Tomasz Grzelewski, MDPhD
- Phone Number: 48426895972
- Email: alergol@kopernik.lodz.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 14 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with allergic diseases, healthy children.
Description
Inclusion Criteria:
- Children with allergic diseases, healthy children.
Exclusion Criteria:
- Other serious diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children suspected of allergic diseases
Children suspected of allergic diseases No intervention
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung function (LF)
Time Frame: 7 years
|
spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test
|
7 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional exhaled nitric oxide (FeNO)
Time Frame: 7 years
|
Fractional exhaled nitric oxide (Sievers equipment)
|
7 years
|
|
Immunoglobulin E (IgE) allergen specific
Time Frame: 7 years
|
Immunoglobulin E (IgE) allergen specific (ELISA method)
|
7 years
|
|
Treatment of asthma (drugs and dosages)
Time Frame: 7 years
|
Treatment of asthma (drugs and dosages last 3 months before measurement of lung function parameters and FeNO)
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Iwona Stelmach, MDPhDProf, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
- Principal Investigator: Tomasz Grzelewski, MDPhD, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Jerzynska 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.
- Grzelewski 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
March 1, 2014
Study Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
February 25, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (Estimate)
March 6, 2013
Study Record Updates
Last Update Posted (Estimate)
September 9, 2013
Last Update Submitted That Met QC Criteria
September 6, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Skin Diseases, Eczematous
- Dermatitis
- Rhinitis
- Rhinitis, Allergic
- Eczema
- Dermatitis, Atopic
- Urticaria
Other Study ID Numbers
- RNN/23/13/KE
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