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Exercise-induced Bronchoconstriction in School Children

This study is currently recruiting participants.
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01798823
First received: February 19, 2013
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

The goal of the project is to define the prevalence and inflammatory background of exercise-induced bronchoconstriction (EIB) in school children and determine individual and environmental risk factors for EIB. The obtained results will provide objective measures on biological processes leading to bronchoconstriction during exercise, as might be experienced naturally during the school life. The results could be applied in the management of EIB patients with or without asthma. The results of planned research will be published in journals with national and international impact, and presented during symposia and conferences.


Condition Intervention
Asthma
 Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise-induced Bronchoconstriction in School Children - Prevalence, Environmental/Individual Risk Factors and Its Mechanism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • - Prevalence and inflammatory background of exercise-induced bronchoconstriction (EIB) in school children, individual and environmental risk factors for EIB [ Time Frame: 26 days (maximal) ] [ Designated as safety issue: No ]
    - prevalence and inflammatory background of exercise-induced bronchoconstriction (EIB) in school children, individual and environmental risk factors for EIB: Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.


Biospecimen Retention:   Samples With DNA
  • exhaled breath condensate sample
  • blood sample (5 ml sample): tryptase, lipoxin A4 serum levels
  • blood sample also will be taken before and after challenge together with exhaled breath condensate sample in order to detect markers of inflammation (such as IL-1a, IL-2, IL-5, IL-6, IL-8, IL-9, IL-12p70, IL-13, IL-17, IL-22, MCP1, TLR2, MIP1a, PDGFBB, TIMP2, TNFalfa, CRP, TGF-b1, TSLP- ELISA and cysteinyl leukotrienes, LTB4, PGE2-HPLC/mass spectrometry).

Estimated Enrollment: 1200
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EIB+A+
  • children with EIB and asthma
  • History, physical, LF, SPT, blood sample, FeNO, EBC
 Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.
Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.
EIB+A-
  • children with EIB without asthma
  • History, physical, LF, SPT, blood sample, FeNO, EBC
 Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.
Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.
EIB-A+
  • children without EIB and asthma
  • History, physical, LF, SPT, blood sample, FeNO, EBC
 Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.
Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.
EIB-A-
  • children without EIB without asthma
  • History, physical, LF, SPT, blood sample, FeNO, EBC
 Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.
Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

school-children screened for EIB during PE lesson

Criteria

Inclusion Criteria:

  • Children with decreased FEV1 (>=10% from baseline) and/or children with EIB history within last 12 months (symptoms: dyspnea, cough, wheezes, chest pain during/after exercises)

Exclusion Criteria:

  • Children without decreased FEV1 (>=10% from baseline) and/or children without EIB history within last 12 months (symptoms: dyspnea, cough, wheezes, chest pain during/after exercises)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798823

Contacts
Contact: Iwona Stelmach, MDPhDProf. 48426895972 alergol@kopernik.lodz.pl
Contact: Paweł Majak, MDPhD 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, MDPhD Prof.     48426895972     alergol@kopernik.lodz.pl    
Contact: Paweł Majak, MD PhD     48426895972     alergol@kopernik.lodz.pl    
Principal Investigator: Iwona Stelmach, MDPhD, Prof.            
Sub-Investigator: Paweł Majak, MD, PhD            
Sub-Investigator: Włodzimierz Stelmach, MD, PhD            
Sub-Investigator: Joanna Jerzyńska, MD, PhD            
Sub-Investigator: Łukasz Cichalewski, MD            
Sub-Investigator: Anna Kozubkiewicz, Msc            
Sub-Investigator: Magdalena Bojo, MD            
Sub-Investigator: Adam Rzeźnicki, MD            
Sub-Investigator: Magdalena Miazek, MD            
Sub-Investigator: Monika Kopka, MD            
Sub-Investigator: Magdalena Koczkowska, MD            
Sub-Investigator: Tomasz Grzelewski, MD, PhD            
Sub-Investigator: Joanna Sieniawska, MD            
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Iwona Stelmach, MDPhDProf. Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland , 93-513
  More Information

No publications provided

Responsible Party: Iwona Stelmach, MD, PhD, Prof., Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT01798823     History of Changes
Other Study ID Numbers: RNN/160/12/KE
Study First Received: February 19, 2013
Last Updated: February 22, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
children
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013