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

Asthma Clinical Trial

— EHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01754948
• Other study ID #: 0488
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2012
• Last updated: December 20, 2012
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Shira Benor, MD
• Phone: +972527360276
• Email: shirabenor[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirometry values	forced expiratory volume at one second	1 sec	No
Secondary	methacholine and adenosine challenge test results	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	1 sec	No