NCT01805635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

February 25, 2013

Last Update Submit

September 6, 2013

Conditions

AsthmaAllergic RhinitisAtopic DermatitisUrticariaHealthy

Keywords

ChildrenAsthmaAllergic rhinitisAtopic dermatitisUrticariaHealthy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Lung function (LF)

    7 years

Other Outcomes (3)

  • Fractional exhaled nitric oxide (FeNO)

    7 years

  • Immunoglobulin E (IgE) allergen specific

    7 years

  • Treatment of asthma (drugs and dosages)

    7 years

Study Arms (1)

Children suspected of allergic diseases

Children suspected of allergic diseases No intervention

Other: No intervention

Interventions

No interventionOTHER

No intervention

Children suspected of allergic diseases

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with allergic diseases, healthy children.

You may qualify if:

  • Children with allergic diseases, healthy children.

You may not qualify if:

  • Other serious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lodz, 93-513, Poland

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26628565DERIVED

  • 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.

    PMID: 26216360DERIVED

  • 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.

    PMID: 24019244DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

IgE specific allergen antibodies

MeSH Terms

Conditions

AsthmaRhinitis, AllergicDermatitis, AtopicUrticaria

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, Vascular

Study Officials

  • Iwona Stelmach, MDPhDProf

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

    STUDY CHAIR

  • Tomasz Grzelewski, MDPhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iwona Stelmach, MDPhDProf

CONTACT

48426895972alergol@kopernik.lodz.pl

Tomasz Grzelewski, MD PhD

CONTACT

48426895972alergol@kopernik.lodz.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDPhDProf

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 6, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

PL(1)