Reversal of Tobacco-Related Sinusitis

Rhinosinusitis Clinical Trial

Official title:

Reversal of Tobacco-Related Sinusitis (Flight Attendant Medical Research Institute (FAMRI) Young Clinical Scientist Award)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843869
• Other study ID #: F080623004
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: March 24, 2015
• Start date: August 2008
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinosinusitis

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Flight Attendant Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of passive or active smoke exposure	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.	Completion of study	No