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

• Conditions: Asthma

• Registration Number: NCT01754948
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-12
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Study First Posted: 2012-12-21
• Last Update Posted: 2012-12-21
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
spirometry values	1 sec	forced expiratory volume at one second

Secondary Outcome Measures

Name	Time	Method
methacholine and adenosine challenge test results	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

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel