Reversal of Tobacco-Related Sinusitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
Brad Woodworth, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00843869
First received: February 12, 2009
Last updated: April 9, 2014
Last verified: April 2014

February 12, 2009
April 9, 2014
August 2008
July 2014   (final data collection date for primary outcome measure)
prevalence of passive or active smoke exposure [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00843869 on ClinicalTrials.gov Archive Site
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Reversal of Tobacco-Related Sinusitis
Reversal of Tobacco-Related Sinusitis (Flight Attendant Medical Research Institute (FAMRI) Young Clinical Scientist Award)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Zinc levels and hair samples will be collected.

Non-Probability Sample

Patients with chronic rhinosinusitis undergoing routine sinus and skull base surgery

Chronic Rhinosinusitis
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Chronic Rhinosinusitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
November 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00843869
F080623004
No
Brad Woodworth, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Flight Attendant Medical Research Institute
Principal Investigator: Brad Woodworth, MD University of Alabama at Birmingham
University of Alabama at Birmingham
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP