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Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458627
First Posted: April 11, 2007
Last Update Posted: April 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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): 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:
ClinicalTrials.gov Identifier: NCT00458627     History of Changes
Other Study ID Numbers: 2044-CTIL
First Submitted: April 10, 2007
First Posted: April 11, 2007
Last Update Posted: April 11, 2007
Last Verified: April 2007

Keywords provided by Rambam Health Care Campus:
Plethysmograpy
preschool
methacholine challenge
spirometry
asthma

Additional relevant MeSH terms:
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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