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

NCT00814281 | Completed

• 1 other identifier: MU2007-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Inflammation

Keywords

particulate air pollution; leukotriene; asthma; montelukast; vascular endothelial dysfunction; nitric oxide(NO)endothelin (ET) system

Outcome Measures

Primary Outcomes (1)

• Exposure to airborne ultrafine and fine particulate matter causes vascular dysfunction.

  February 2009

Secondary Outcomes (1)

• Montelukast protects against pollution induced vascular dysfunction.

  February 2009

Study Arms (4)

1

PLACEBO COMPARATOR

Subject will exercise in high levels of ultrafine and fine particulate air pollution 1 hour after ingesting a placebo.

Other: placebo

2

PLACEBO COMPARATOR

Subject will exercise in low levels of ultrafine and fine particulate air pollution 1 hour after ingesting a placebo.

Other: placebo

3

EXPERIMENTAL

Subject will exercise in high levels of ultrafine and fine particulate air pollution 1 hour after ingesting Montelukast 10 mg orally.

Drug: Montelukast

4

EXPERIMENTAL

Subject will exercise in low levels of ultrafine and fine particulate air pollution 1 hour after ingesting Montelukast 10 mg orally.

Drug: Montelukast

Interventions

placebo OTHER

Placebo

Also known as: Sugar Pill

1; 2

Montelukast DRUG

10 mg ingested orally 1 hour prior to exercise testing

Also known as: Singulair

3; 4

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects
• between 18 and 30 years of age
• participant in endurance sport

You may not qualify if:

• history of blood clotting
• history of coagulation problems
• History of spontaneous pneumothorax

Sponsors & Collaborators

• Marywood University: lead

Study Sites (1)

Marywood University

Scranton, Pennsylvania, 18509, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Sugars; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Kenneth W Rundell, PhD

  Marywood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 24, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

US (1)