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Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years (MCH-preschool)

Primary Purpose

Asthma, Recurrent Cough

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methachoine
spirometry
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring Methacholine challenge; Spirometry, Early childhood

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 3- to 6-years
  • respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9]
  • cough duration of more than 4 weeks
  • normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing.

Exclusion Criteria:

  • presence of other chronic respiratory conditions
  • emergency room visit or the presence of respiratory infection within the last month
  • oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
  • bronchodilator taken within 24-hours prior to the test.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 20, 2007
    Last Updated
    October 29, 2007
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00550758
    Brief Title
    Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years
    Acronym
    MCH-preschool
    Official Title
    The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    the study has recently ended, all information gathred as planed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.
    Detailed Description
    We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital. Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine). Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Recurrent Cough
    Keywords
    Methacholine challenge; Spirometry, Early childhood

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Methachoine
    Intervention Description
    inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)
    Intervention Type
    Device
    Intervention Name(s)
    spirometry
    Intervention Description
    spirometry
    Primary Outcome Measure Information:
    Title
    Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
    Time Frame
    after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 3- to 6-years respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9] cough duration of more than 4 weeks normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing. Exclusion Criteria: presence of other chronic respiratory conditions emergency room visit or the presence of respiratory infection within the last month oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks bronchodilator taken within 24-hours prior to the test.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lea Bentur, MD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Daphna Vilozni, PhD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years

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