Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood - Full Text View

Purpose

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.

Condition
Asthma

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective
Official Title:	Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment:	50
Study Start Date:	February 2006
Estimated Study Completion Date:	September 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

2.5-6.9 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458627

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:	Lea Bentur, MD	Rambam medical Center, Haifa, Israel
Principal Investigator:	Daphna Vilozni, PhD	Rambam Health Care Campus

More Information

Publications:

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.

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.

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. Review. No abstract available.

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. No abstract available.

ClinicalTrials.gov Identifier:	NCT00458627 History of Changes
Other Study ID Numbers:	2044-CTIL
Study First Received:	April 10, 2007
Last Updated:	April 10, 2007
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Plethysmograpy
preschool
methacholine challenge
spirometry
asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methacholine Chloride
Miotics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013