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EHF: Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01754948
Collaborator
(none)
100
Enrollment
1
Location
11
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied.

Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children
    Study Start Date :
    Jul 1, 2012
    Anticipated Primary Completion Date :
    Jun 1, 2013
    Anticipated Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. spirometry values [1 sec]

      forced expiratory volume at one second

    Secondary Outcome Measures

    1. methacholine and adenosine challenge test results [1 sec]

      provocative concentration causing a 20% fall in forced expiratory volume at one second and provocative dose causing a 20% fall in forced expiratory volume at one second

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 6-18 years

    • living in the Tel Aviv area

    • referred to the pulmonology lab for respiratory function evaluation

    Exclusion Criteria:

    • Exposure to cigarette smoke

    • Respiratory infection in the 4 weeks prior to recruitment and testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tel Aviv Medical Center Tel Aviv Israel

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    • Study Director: Shira Benor, MD, Tel Aviv Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tel-Aviv Sourasky Medical Center
    ClinicalTrials.gov Identifier:
    NCT01754948
    Other Study ID Numbers:
    • 0488
    First Posted:
    Dec 21, 2012
    Last Update Posted:
    Dec 21, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Tel-Aviv Sourasky Medical Center
    asthma
    reactive airway disease
    cough
    air pollution
    nano particles
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Dec 21, 2012