NCT00815984

Brief Summary

In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

December 30, 2008

Last Update Submit

February 9, 2010

Conditions

Keywords

AsthmaAllergic RhinitisAtopic DermatitisChildrenlung functionskin prick testsFeNO

Outcome Measures

Primary Outcomes (1)

  • Concentration of nitric oxide in exhaled breath.

    1-4 months

Study Arms (1)

Schoolchildren with asthma.

Schoolchildren with asthma.

Procedure: measurements of lung function tests

Interventions

Measurement of the concentration of FeNO , measurement of spirometry, plethysmography, exercise challenge test (ECT -spirometric), bronchial obstruction reversibility pharmacological test

Also known as: NO analyzer- Sievers 280i analyzer, Spirometry and Plethysmography - Jaeger, Exercise provocation test treadmill- Kettler
Schoolchildren with asthma.

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis

You may qualify if:

  • Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis

You may not qualify if:

  • Other chronic diseases
  • Asthma exacerbation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics and Allergy, N. Copernicus Hospital

Lodz, 93-513, Poland

Location

Related Publications (1)

  • Grzelewski T, Majak P, Jerzynska J, Stelmach W, Stelmach R, Janas A, Grzelewska A, Witkowski K, Makandjou-Ola E, Stelmach I. The interpretation of exhaled nitric oxide values in children with asthma depends on the degree of bronchoconstriction and the levels of asthma severity. Respir Care. 2014 Sep;59(9):1404-11. doi: 10.4187/respcare.02889. Epub 2013 Dec 31.

MeSH Terms

Conditions

AsthmaRhinitis, AllergicDermatitis, Atopic

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, Eczematous

Study Officials

  • Iwona Stelmach, MD PhD Prof

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

    STUDY CHAIR
  • Tomasz Grzelewski, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2008

First Posted

December 31, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 10, 2010

Record last verified: 2010-02

Locations