The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers

• Conditions: Inadequate or Impaired Respiratory Function

• Registration Number: NCT01599845
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.

Detailed Description

This study investigates the following questions:

Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.

Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.

The study protocol includes the following steps:

Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.

Study Timeline

• Study First Submitted: 2012-04-29
• Status Verified: 2012-05
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Study First Posted: 2012-05-16
• Last Update Posted: 2012-05-16
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
• Study population is composed of people who are exposed to environmental particles form industrial sources.
• Informed consent is requested from each subject.

Exclusion Criteria

• Unemployed individuals.
• Individuals who are not working in industrial jobs, such as office workers and secretaries.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the size distribution of nano-particles in exhaled breath condensate	One year	Each subject will be examined once. The total time for collection of data is estimated as about one year.