Clinical trial NCT00843869: Reversal of Tobacco-Related Sinusitis
Official title: Reversal of Tobacco-Related Sinusitis (Flight Attendant Medical Research Institute (FAMRI) Young Clinical Scientist Award)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinosinusitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
First posted: 2009-02-13
Enrollment: 282
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rhinosinusitis undergoing routine sinus and skull base surgery

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.

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.

Primary outcomes:
measure: prevalence of passive or active smoke exposure
timeFrame: Completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Brad Woodworth, MD
role: PRINCIPAL_INVESTIGATOR
References: