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Exercise-induced Bronchoconstriction in School Children

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ClinicalTrials.gov Identifier: NCT01798823
Recruitment Status : Unknown
Verified February 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz

Brief Summary:
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 or disease Intervention/treatment
Asthma Procedure: History, physical, LF, SPT, blood sample, FeNO, EBC.

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise-induced Bronchoconstriction in School Children - Prevalence, Environmental/Individual Risk Factors and Its Mechanism
Study Start Date : February 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. - Prevalence and inflammatory background of exercise-induced bronchoconstriction (EIB) in school children, individual and environmental risk factors for EIB [ Time Frame: 26 days (maximal) ]
    - 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).


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Iwona Stelmach, Medical Universtity of Lodz:
children
asthma