PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01805635|
Recruitment Status : Unknown
Verified September 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was: Recruiting
First Posted : March 6, 2013
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment|
|Asthma Allergic Rhinitis Atopic Dermatitis Urticaria Healthy||Other: No intervention|
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|
|Estimated Enrollment :||5500 participants|
|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|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||April 2014|
Children suspected of allergic diseases
Children suspected of allergic diseases No intervention
Other: No intervention
- 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
- Lung function (LF) [ Time Frame: 7 years ]spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test
- Fractional exhaled nitric oxide (FeNO) [ Time Frame: 7 years ]Fractional exhaled nitric oxide (Sievers equipment)
- Immunoglobulin E (IgE) allergen specific [ Time Frame: 7 years ]Immunoglobulin E (IgE) allergen specific (ELISA method)
- 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)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805635
|Contact: Iwona Stelmach, MDPhDProffirstname.lastname@example.org|
|Contact: Tomasz Grzelewski, MD PhDemail@example.com|
|Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital||Recruiting|
|Lodz, Poland, 93-513|
|Contact: Iwona Stelmach, MDPhDProf 48426895972 firstname.lastname@example.org|
|Contact: Tomasz Grzelewski, MDPhD 48426895972 email@example.com|
|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|