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Body Plethysmograph Measurements Before and After Methacholine Challenge in Early Childhood

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00458627
First received: April 10, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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
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

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

ClinicalTrials.gov processed this record on November 20, 2014