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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01805635
First received: February 25, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Asthma
Allergic Rhinitis
Atopic Dermatitis
Urticaria
Healthy
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • Allergic disease diagnosis [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    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:
  • Lung function (LF) [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    spirometry, whole-body pletysmography, occlusion resistance, bronchial reversibility test


Other Outcome Measures:
  • Fractional exhaled nitric oxide (FeNO) [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Fractional exhaled nitric oxide (Sievers equipment)

  • Immunoglobulin E (IgE) allergen specific [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Immunoglobulin E (IgE) allergen specific (ELISA method)

  • Treatment of asthma (drugs and dosages) [ Time Frame: 7 years ] [ Designated as safety issue: No ]
    Treatment of asthma (drugs and dosages last 3 months before measurement of lung function parameters and FeNO)


Biospecimen Retention:   Samples With DNA

IgE specific allergen antibodies


Estimated Enrollment: 5500
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children suspected of allergic diseases
Children suspected of allergic diseases No intervention
Other: No intervention
No intervention
Other Name: No intervention

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).
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with allergic diseases, healthy children.

Criteria

Inclusion Criteria:

  • Children with allergic diseases, healthy children.

Exclusion Criteria:

  • Other serious diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805635

Contacts
Contact: Iwona Stelmach, MDPhDProf 48426895972 alergol@kopernik.lodz.pl
Contact: Tomasz Grzelewski, MD PhD 48426895972 alergol@kopernik.lodz.pl

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital Recruiting
Lodz, Poland, 93-513
Contact: Iwona Stelmach, MDPhDProf    48426895972    alergol@kopernik.lodz.pl   
Contact: Tomasz Grzelewski, MDPhD    48426895972    alergol@kopernik.lodz.pl   
Sponsors and Collaborators
Medical Universtity of Lodz
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
  More Information

No publications provided by Medical Universtity of Lodz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iwona Stelmach, MDPhDProf, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT01805635     History of Changes
Other Study ID Numbers: RNN/23/13/KE
Study First Received: February 25, 2013
Last Updated: September 6, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
Children
Asthma
Allergic rhinitis
Atopic dermatitis
Urticaria
Healthy

Additional relevant MeSH terms:
Urticaria
Asthma
Dermatitis
Dermatitis, Atopic
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular

ClinicalTrials.gov processed this record on August 28, 2014