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NCT01805635 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01805635
Other study ID # RNN/23/13/KE
Secondary ID
Status Recruiting
Phase N/A
First received February 25, 2013
Last updated September 6, 2013
Start date February 2013
Est. completion date April 2014

Study information
Verified date September 2013
Source Medical Universtity of Lodz
Contact Iwona Stelmach, MDPhDProf
Phone 48426895972
Email alergol@kopernik.lodz.pl
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Observational

Clinical 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 5500
Est. completion date April 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- Children with allergic diseases, healthy children.

Exclusion Criteria:

- Other serious diseases.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Poland Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital Lodz

Sponsors (1)
Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Other Fractional exhaled nitric oxide (FeNO) Fractional exhaled nitric oxide (Sievers equipment) 7 years No
Other Immunoglobulin E (IgE) allergen specific Immunoglobulin E (IgE) allergen specific (ELISA method) 7 years No
Other Treatment of asthma (drugs and dosages) Treatment of asthma (drugs and dosages last 3 months before measurement of lung function parameters and FeNO) 7 years No
Primary 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 7 years No
Secondary Lung function (LF) spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test 7 years No
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