Reversal of Tobacco-Related Sinusitis

NCT ID: NCT00843869

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-02-28

Brief Summary

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This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.

Detailed Description

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By using patient screening questionnaires and measuring hair nicotine, a well acknowledged biomarker of exposure to tobacco smoke, we will attempt a more objective study to examine the association between tobacco smoke and chronic rhinosinusitis. (CRS) Likewise, zinc deficiency is documented in numerous animal and human studies to decrease resistance to infectious diseases and is especially common among smokers. We will explore our hypothesis that SHS exposure and zinc deficiency contribute to CRS. To accomplish this, we will measure serum zinc and hair nicotine levels in CRS patients and correlate them to a variety of CRS diagnostic indicators. A second objective of this study is investigating alterations within the epithelium lining the sinonasal cavities in patients with chronic rhinosinusitis. The alterations may be one or a combination of anatomic, genetic, inflammatory, or infectious etiologies. To further investigate these possibilities we plan on taking residual clinical material from endoscopic sinus surgery specimens and performing various in vitro investigations including but not limited to microarray analysis, northern and western blot analysis, ciliary beat frequency analysis, immunohistochemistry, electron microscopy, and propagation of tissue with tissue culture techniques. Tissues taken from non-sinusitis patients undergoing sinonasal surgery will serve as a non-chronic rhinosinusitis control source of sinus mucosa.

Conditions

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Rhinosinusitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Rhinosinusitis

Participants with chronic rhinosinusitis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* CRS and skull base surgery patients; CRS patients that meet the objective and subjective guidelines for CRS set forth by the Sinus and Allergy Health Partnership.

Exclusion Criteria

* Ciliary dysfunction, autoimmune disease, CF or any known immunodeficiency.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flight Attendant Medical Research Institute

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Brad Woodworth, MD

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brad Woodworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F080623004

Identifier Type: -

Identifier Source: org_study_id

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