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Reversal of Tobacco-Related Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843869
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
Brad Woodworth, MD, University of Alabama at Birmingham

Tracking Information
First Submitted Date February 12, 2009
First Posted Date February 13, 2009
Last Update Posted Date March 25, 2015
Study Start Date August 2008
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2013)
prevalence of passive or active smoke exposure [ Time Frame: Completion of study ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reversal of Tobacco-Related Sinusitis
Official Title Reversal of Tobacco-Related Sinusitis (Flight Attendant Medical Research Institute (FAMRI) Young Clinical Scientist Award)
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Zinc levels and hair samples will be collected.
Sampling Method Non-Probability Sample
Study Population Patients with chronic rhinosinusitis undergoing routine sinus and skull base surgery
Condition Rhinosinusitis
Intervention Not Provided
Study Groups/Cohorts Chronic Rhinosinusitis
Participants with chronic rhinosinusitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 24, 2015)
282
Original Estimated Enrollment
 (submitted: February 12, 2009)
150
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00843869
Other Study ID Numbers F080623004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Brad Woodworth, MD, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators Flight Attendant Medical Research Institute
Investigators
Principal Investigator: Brad Woodworth, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2015