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

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ClinicalTrials.gov Identifier: NCT01754948
Recruitment Status : Unknown
Verified December 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : December 21, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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
Asthma

Study Type : Observational
Estimated 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 : July 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. spirometry values [ Time Frame: 1 sec ]
    forced expiratory volume at one second


Secondary Outcome Measures :
  1. methacholine and adenosine challenge test results [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
asthmatic and control children
Criteria

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

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): NCT01754948


Contacts
Contact: Shira Benor, MD +972527360276 shirabenor@yahoo.com
Contact: Elizabeth Fireman, Phd lizzyf@tlvmc.health.gov.il

Locations
Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel
Contact: Shira Benor, MD       shirabenor@yahoo.com   
Principal Investigator: Shira Benor         
Principal Investigator: Shira Benor, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Director: Shira Benor, MD Tel Aviv Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01754948     History of Changes
Other Study ID Numbers: 0488
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
asthma
reactive airway disease
cough
air pollution
nano particles