NCT00442715

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

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

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

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

March 6, 2007

Status Verified

March 1, 2007

First QC Date

March 1, 2007

Last Update Submit

March 5, 2007

Conditions

Keywords

Exercise-induced asthma,early childhood;spirometry,exercise challengeData from preschool children who were referred to the PediatricPulmonary Clinic over a 1-year period were recruited

Interventions

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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: 16162700BACKGROUND
  • Aurora 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: 15028561BACKGROUND
  • Crapo 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: 10619836BACKGROUND
  • Godfrey 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

AsthmaAsthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesExercise-Induced Allergies

Study Officials

  • Daphna Vilozni, PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations