Exercise Challenge Test in 3-6 Years Old Asthmatic Children
1 other identifier
observational
100
1 country
1
Brief Summary
Vigorous exercise is known to cause transient bronchoconstriction in school children with asthma, many of whom initially have normal lung function at rest. The presence and extent of this phenomena in early childhood is difficult to recognize, because exercise induced bronchoconstriction (EIB) may not limit the child's performance and the child may fail to notice the symptoms until taking part in organized or competitive sport. Conversely, as children do participate in vigorous activities all day long, severe EIB may provoke a crucial disabling condition in the child. In school children the exercise challenge test (ECT) is a well standardized test and is used to make a diagnosis of asthma because it is able to discriminate between asthma and other chronic breathing illnesses of childhood and is also used to determine the effectiveness and optimal dosages of medications prescribed to prevent EIB. The test includes is a controlled run on a motor-driven treadmill followed by scheduled multiple spirometry maneuvers. This procedure was never been tested and may not be suitable for the preschool age. In this study we assumed that a free-run test which combined with measurements of duplicate spirometry-sets would be the most convenient way to test young children. The aims of this study are a) to examine the feasibility of a free-run protocol (according to the ATS/ERS recomendations), followed by duplicate spirometry measurements in early childhood. b) to explore the existence of exercise induced bronchoconstriction in young children (age 3-6 years old) with respiratory symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 1, 2007
CompletedFirst Posted
Study publicly available on registry
March 2, 2007
CompletedMarch 6, 2007
March 1, 2007
March 1, 2007
March 5, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- year-old children referred for exercise challenge test by pediatric physicians.
You may not qualify if:
- presence of other chronic respiratory conditions (e.g. cystic fibrosis, bronchopulmonary dysplasia); oral or inhaled steroids taken during the previous week; bronchodilator taken within 24 hours prior to the test; wheezing at physical examination prior to exercise test, and baseline FEV1\< 70 % predicted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric pulmonary unit, The Edmod and Lili Safra children's Hospital, Sheba Medical Center
Ramat Gan, 52625, Israel
Related Publications (4)
Vilozni D, Barak A, Efrati O, Augarten A, Springer C, Yahav Y, Bentur L. The role of computer games in measuring spirometry in healthy and "asthmatic" preschool children. Chest. 2005 Sep;128(3):1146-55. doi: 10.1378/chest.128.3.1146.
PMID: 16162700BACKGROUNDAurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med. 2004 May 15;169(10):1152-9. doi: 10.1164/rccm.200310-1453OC. Epub 2004 Mar 17.
PMID: 15028561BACKGROUNDCrapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
PMID: 10619836BACKGROUNDGodfrey S, Springer C, Bar-Yishay E, Avital A. Cut-off points defining normal and asthmatic bronchial reactivity to exercise and inhalation challenges in children and young adults. Eur Respir J. 1999 Sep;14(3):659-68. doi: 10.1034/j.1399-3003.1999.14c28.x.
PMID: 10543290BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daphna Vilozni, PhD
Sheba Medical Center
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 1, 2007
First Posted
March 2, 2007
Study Start
October 1, 2006
Study Completion
December 1, 2006
Last Updated
March 6, 2007
Record last verified: 2007-03