Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

Airway Inflammation Clinical Trial

Official title:

Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814281
• Other study ID #: MU2007-005
• Status: Completed
• Phase: N/A
• First received: December 22, 2008
• Last updated: May 20, 2009
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Marywood University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine biological pathways of altered blood vessel function resulting from breathing airborne particulate. Blood artery function in healthy men will be measured after particulate exposure either on placebo or on an asthma medication that stops production of an inflammatory biological agent. Lung and blood profiles will be obtained before and after exposure to exhaust fumes. We believe that the inflammatory agent produced by the lungs from breathing these particles causes abnormal artery function.

Description:

Hourly ice resurfacing by gas and propane fueled machines creates high levels of ultrafine and fine particulate matter (PM1) in indoor ice rinks. PM1 exposure may disrupt the normal nitric oxide (NO)/endothelin (ET)-1 vasodilation system and promote atherosclerosis, and/or increase the risk of an acute cardiac event. Our specific aims are 1) to determine whether impaired endothelial-mediated vasodilation and forearm muscle tissue reoxygenation rate and blood volume change (to reactive hyperemia following artery occlusion) is associated with combustion-derived PM1 exposure, and 2) To characterize a PM1 induced mechanism of endothelial dysfunction which occurs via a leukotriene (LT)-associated, airway generated tumor necrosis factor-alpha (TNF-a) mediated pathway. Healthy low PM1 exposed males will be evaluated for endothelial dysfunction before and after artery occlusion using high resolution ultrasound and near-infrared spectroscopy (NIRS), before and after moderate exercise in blinded high and low [PM1]. Endothelial dysfunction among chronically PM¬1 exposed ice rink athletes will be determined to evaluate the feasibility of using this population as a model in future studies. TNF-a, IL-8, LTB4, LTC4, LTD4, LTE4, ET-1, NO, and differential cell counts will be measured in sputum and serum. [PM1] will be monitored and exposure levels will be typical of indoor ice rinks. LT involvement will be assessed in vivo by double-blind pharmacological manipulation during PM1 exposure during light exercise. Results will demonstrate whether endothelial-mediated vasodilation and muscle hemodynamics are influenced by PM1 exposure, and will elucidate an LT initiated TNF-a mediated pathway in ET-1 upregulation. Our results should provide information for understanding the effects of PM1 exposure on the atherosclerotic process and cardiovascular risk, and give insight to novel treatment and diagnostic modalities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects

• between 18 and 30 years of age

• participant in endurance sport

Exclusion Criteria:

• history of blood clotting

• history of coagulation problems

• History of spontaneous pneumothorax

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Airway Inflammation
• Inflammation

Intervention

Other:
• placebo
Placebo

Drug:
• Montelukast
10 mg ingested orally 1 hour prior to exercise testing

Locations

Country	Name	City	State
United States	Marywood University	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marywood University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to airborne ultrafine and fine particulate matter causes vascular dysfunction.		February 2009	No
Secondary	Montelukast protects against pollution induced vascular dysfunction.		February 2009	No