Lung Mucus Hypersecretion and NQO1

NCT00729352 | Completed

• 3 other identifiers: 16347-CP-00100008404R01ES016347
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The research plan proposes translational studies in relevant animal models and human subjects in order to identify host (genetic) susceptibility factors that confer vulnerability to the prototypal air pollutant, ozone. The results will have significant impact upon, and aid in, understanding mechanisms regulating pro-oxidant lung injury, production and secretion of airway mucins, and clearance of respiratory mucus, and adverse health effects, that occur during and following exposure to airborne respiratory irritants.

Conditions

Environmental Exposure; Ozone; Air Pollution; Genetic Susceptibility

Keywords

NQO1, ozone, airway mucociliary clearance.

Outcome Measures

Primary Outcomes (1)

• Airway Mucociliary Clearance

  6-24 h post-exposure to filatered air or ozone.

Secondary Outcomes (1)

• Bronchial Epithelial Cells obtained by bronchoalveolar lavage.

  6-24 h post-exposure to filtered air or ozone.

Study Arms (2)

Control group

18-35 yr old healthy subjects with wild type genotype for NQO1.

Case group

18-35 yr old healthy subjects who are homozygotic for minor allele of NQO1 Pro187Ser polymorphism

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be healthy adults, non-smokers, recruited from the University campus and local community. Fifty% will be female. Recruitment of minority ethnic groups will be consistent with census population for central NC. Subjects will have a clinical history and lung function screening at protocol entry. Female subjects of childbearing age will have pregnancy testing. Equal numbers of NQO1 sufficient and deficient subjects, based upon genoytypic pre-screening and stratified by racial background will be studied. Subjects will also be genotyped for GSTM1 wild type or null genotype. As individuals with an increased BMI may respond strongly to O3 we will only recruit subjects with body habitus within normal range for gender, age, and racial group.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage specimens.

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2012
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

US (1)