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

Inadequate or Impaired Respiratory Function Clinical Trial

— Nanoexposure  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01599845
• Other study ID #: TASMC-11-YS-0107-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 29, 2012
• Last updated: May 14, 2012
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yehuda Schwarz, M.D.
• Phone: 03-6973774
• Email: schwarz.reot[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Inadequate or Impaired Respiratory Function
• Respiratory Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the size distribution of nano-particles in exhaled breath condensate	Each subject will be examined once. The total time for collection of data is estimated as about one year.	One year	Yes