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

NCT01754948 | Unknown

• 1 other identifier: 0488
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; reactive airway disease; cough; air pollution; nano particles

Outcome Measures

Primary Outcomes (1)

• spirometry values

  forced expiratory volume at one second

  1 sec

Secondary Outcomes (1)

• methacholine and adenosine challenge test results

  1 sec

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

asthmatic and control children

You may qualify if:

• age 6-18 years
• living in the Tel Aviv area
• referred to the pulmonology lab for respiratory function evaluation

You may not qualify if:

• Exposure to cigarette smoke
• Respiratory infection in the 4 weeks prior to recruitment and testing

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Cough

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Shira Benor, MD

  Tel Aviv Medical Center

  STUDY DIRECTOR

Central Study Contacts

Shira Benor, MD

CONTACT

+972527360276; shirabenor@yahoo.com

Elizabeth Fireman, Phd

CONTACT

lizzyf@tlvmc.health.gov.il

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

IL (1)