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

NCT ID: NCT01805635

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-04-30

Brief Summary

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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

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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).

Conditions

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Asthma Allergic Rhinitis Atopic Dermatitis Urticaria Healthy

Keywords

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Children Asthma Allergic rhinitis Atopic dermatitis Urticaria Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children suspected of allergic diseases

Children suspected of allergic diseases No intervention

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with allergic diseases, healthy children.

Exclusion Criteria

* Other serious diseases.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Iwona Stelmach

MDPhDProf

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iwona Stelmach, MDPhDProf

Role: STUDY_CHAIR

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

Tomasz Grzelewski, MDPhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Iwona Stelmach, MDPhDProf

Role: CONTACT

Phone: 48426895972

Email: [email protected]

Tomasz Grzelewski, MD PhD

Role: CONTACT

Phone: 48426895972

Email: [email protected]

Facility Contacts

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Iwona Stelmach, MDPhDProf

Role: primary

Tomasz Grzelewski, MDPhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 26628565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26216360 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24019244 (View on PubMed)

Other Identifiers

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RNN/23/13/KE

Identifier Type: -

Identifier Source: org_study_id