NCT00458627

Brief Summary

In our previous study of Methacholine Challenge Tests (MCT) in preschool children, we found that wheeze detection was associated with significant reduction in flows and vital capacity values. We hypothesized that this finding is associated with trapped-air rather than the children's loss of cooperation/concentration. Objectives: To test this hypothesis by attempting plethysmography measurements during MCT.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

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

February 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

April 10, 2007

Last Update Submit

April 10, 2007

Conditions

Keywords

Plethysmograpypreschoolmethacholine challengespirometryasthma

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • year-old children who were asthmatic according to GINA guidelines.
  • All children previously had recurrent episodes of wheeze, cough and/or shortness of breath with clinical response to bronchodilator.
  • Children were included only if they had not received anti-inflammatory medication for at least one week prior to the test or bronchodilators for at least 24 hours prior to the study.
  • On the day of testing, children were included if they had normal chest auscultation and FEV1\>75% predicted for healthy preschool children.

You may not qualify if:

  • Presence of other chronic respiratory conditions
  • Emergency room visit in the past three months
  • Respiratory infection in the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bentur L, Beck R, Elias N, Barak A, Efrati O, Yahav Y, Vilozni D. Methacholine bronchial provocation measured by spirometry versus wheeze detection in preschool children. BMC Pediatr. 2005 Jun 28;5:19. doi: 10.1186/1471-2431-5-19.

    PMID: 15985169BACKGROUND
  • 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
  • Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.

    PMID: 16135736BACKGROUND
  • 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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lea Bentur, MD

    Rambam medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR
  • Daphna Vilozni, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

February 1, 2006

Study Completion

September 1, 2006

Last Updated

April 11, 2007

Record last verified: 2007-04