Nasal Polyps, Sinusitis
Conditions
Keywords
PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps
Brief summary
The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).
Detailed description
The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20). The study design involves case control Polymerase Chain reaction (PCR) analysis of nasal mucosal swabs, saliva swabs, blood serum, and home vacuum cleaner bags in patients with sinusitis and normal controls. The hypothesis is that the quantity and type of fungal DNA present in the nose and home environment are directly correlated with quality of life. Our research aims to both quantify the amount of fungi present in the nasal mucosa as well as to measure the severity of the patient's chronic rhinosinusitis (CRS) as a function of SNOT-20 and SF-36 outcomes questionnaires. We hypothesize that the amount and type of fungi present in the nose and home environment will correlate with the severity of the patients' symptoms of CRS.
Interventions
PROCEDURENasal swab under endoscopic guidance
After the application of pontocaine and neosynephrine spray, the following will be done: * A small sponge applicator will be used to swab the inside of your mouth for saliva collection * A blood sample (6cc - one tube) will be collected * A small brush applicator called a cytology brush and an instrument called an endoscope will be used to swab the inside of your nose (middle meatus) * Subjects will be asked to complete 2 standard quality of life questionnaires regarding how much your symptoms bother you * You will be asked to bring in a vacuum cleaner bag from home at a follow-up appointment which will be swabbed as well The samples will be refrigerated and analyzed using PCR to detect and speciate fungus.
Sponsors
Environmental Protection Agency (EPA)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with no sinus disease and subjects with chronic rhinosinusitis.
Exclusion criteria
* Immunocompromise * Pregnancy * Minors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20). | During the course of outpatient visit |
Countries
United States
Outcome results
None listed