Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans

NCT00840528 | Completed

• 2 other identifiers: 02-1416NIH/NIEHS 1RC1ES018417
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The principal purpose of this study is to identify hyper-responsive, responsive and non-responsive groups of healthy human subjects based on their airway neutrophilic response to ozone exposure, and to perform micro-array analyses on DNA collected from recovered airway cells to explore possible differences in gene expression profiles between the three groups

Conditions

Healthy Control

Keywords

ozone

Outcome Measures

Primary Outcomes (1)

• Airway neutrophilic response to ozone exposure

  6-24 hours post challenge

Secondary Outcomes (1)

• expression of specific genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects

  pre/ post exposure

Study Arms (1)

Ozone exposure

EXPERIMENTAL

Exposure to ozone at 0.4ppm

Other: ozone

Interventions

ozone OTHER

0.4 ppm ozone for 2 hours

Also known as: O3

Ozone exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will have an FEV1/FVC equal to or greater than 75%, as well as FVC and FEV1 greater than or equal to 80% of predicted normal for height and age.
• Skin testing will be performed; subjects with active allergies will not be studied while they are symptomatic.
• Subjects must be in good general health with no history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks, and without contraindications for performing sustained light to moderate exercise.
• Subjects must demonstrate the ability to produce an acceptable induced sputum sample during the training session. If the sample is unsatisfactory, the subject's participation will end at this point.
• Antidepressants and other medications may be permitted if in the opinion of the investigator the medication will not interfere with the study procedures or compromise safety; and if the dosage has been stable for 3 months.
• Subjects must smoke less than 10 cigarettes (one half pack) a month for at least 3 years. Individuals who have smoked greater than 10 pack years lifetime will be excluded.
• Subjects must be willing to refrain from strenuous physical activity for 24 hours before and after exposure.

You may not qualify if:

• asthmatic or active allergic rhinitis
• Non English speaking volunteers will be excluded as no one on the study staff is fluent in other languages likely to be encountered.
• use anti-inflammatory medications or medications for asthma

Sponsors & Collaborators

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

Study Sites (1)

US EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• David B Peden, MD, MS

  University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2002
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)