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

This study is currently recruiting participants.
Verified December 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01754948
First received: December 18, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • spirometry values [ Time Frame: 1 sec ] [ Designated as safety issue: No ]
    forced expiratory volume at one second


Secondary Outcome Measures:
  • methacholine and adenosine challenge test results [ Time Frame: 1 sec ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01754948     History of Changes
Other Study ID Numbers: 0488
Study First Received: December 18, 2012
Last Updated: December 20, 2012
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013