Effect Of Obesity On Ozone-Induced Airway Inflammation

NCT00839943 | Completed

• 2 other identifiers: 05-CEMLB-128IRB 05-1644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults.

Conditions

Obesity

Keywords

ozone; clean air

Outcome Measures

Primary Outcomes (1)

• Methacholine reactivity (primary endpoint)

  2-4 hours post exposure

Secondary Outcomes (2)

• Breathing and lung function variables

  immediately post exposure, 24 post exposure

• induced sputum markers

  4 hours post exposure

Study Arms (2)

ozone

ACTIVE COMPARATOR

obese vs non-obese women

Other: ozone, 0.4 ppm

air

ACTIVE COMPARATOR

obese vs non obese women

Other: ozone, 0.4 ppm

Interventions

ozone, 0.4 ppm OTHER

2 hour ozone exposure, 0.40 ppm

air; ozone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Twenty (20) non-obese, non-overweight (body mass index, 18 kg/m2 \> BMI \< 25 kg/m2, waist circumference \< 35 inches) subjects and 20 obese (30 kg/m2 \> BMI \< 38 kg/m2, waist circumference \>= 35 inches) volunteer females between 18-35 yrs of age

You may not qualify if:

• Are female and pregnant or have any reason to believe you might be pregnant.
• Are not between 18 and 35 years old.
• Have a history of asthma or have current hay fever.
• Have ever smoked more than 10 cigarettes (one half pack) a month or smoked during the past 30 days.
• Have a history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks.
• Have contraindications for performing sustained light exercise.
• You've been in a recent or recurring exposure to a dusty environment at work
• If you are unwilling to refrain from strenuous physical activity for 24 hours before and after each exposure.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Environmental Protection Agency (EPA): collaborator

Study Sites (1)

US EPA Human Studies Facility-UNC -CH campus

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Ozone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• William Bennett, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Stephanie London, MD, PhD

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: May 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 27, 2012

Record last verified: 2012-06

Locations

US (1)