PF and FeNO and Clinical Characteristics in Children Being Diagnosed Due to Suspicion of Allergic Diseases

• Conditions: Asthma; Healthy; Allergic Rhinitis; Atopic Dermatitis; Urticaria
• Interventions: Other: No intervention

• Registration Number: NCT01805635
• Lead Sponsor: Medical University of Lodz

Brief 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.

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:

1. FeNO levels.

2. Allergic disease diagnosis.

3. Immunoglobulin E (IgE) specific levels.

4. Treatment (drugs and dosages).

5. Lung function parameters (spirometry, whole-body plethysmography, occlusion resistance, bronchial reversibility test).

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

• Children with allergic diseases, healthy children.

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Exclusion Criteria

• Other serious diseases.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children suspected of allergic diseases	No intervention	Children suspected of allergic diseases No intervention

Primary Outcome Measures

Name	Time	Method
Allergic disease diagnosis	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

Secondary Outcome Measures

Name	Time	Method
Lung function (LF)	7 years	spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test

Trial Locations

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital; 🇵🇱 Lodz, Poland