The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA - Full Text View

Sponsors and Collaborators:	University of California, San Francisco Environmental Protection Agency (EPA)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00739921

Purpose

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).

Condition	Intervention
Sinusitis Nasal Polyps	Procedure: Nasal swab under endoscopic guidance

MedlinePlus related topics: Molds Sinusitis

Drug Information available for: Tetracaine Viractin Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Parallel Assignment
Official Title:	PCR Analysis of Nasal Polyps for Fungal DNA

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20). [ Time Frame: During the course of outpatient visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	187
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients with sinusitis compared to patients without.	Procedure: Nasal swab under endoscopic guidance Patients with and without sinusitis will have a nasal swab taken under endoscopic guidance from their nose (middle meatus) after the application of pontocaine and neosynephrine spray. The swab will be refrigerated and analyzed using PCR to detect and speciate fungus.

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects with no sinus disease and subjects with chronic rhinosinusitis.

Exclusion Criteria:

Immunocompromise
Pregnancy
Minors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739921

Contacts

Contact: Wendy Ma	415-353-2870	wma@ohns.ucsf.edu
Contact: Andrew Murr, MD	415-353-2870	ahmurr@ohns.ucsf.edu

Locations

United States, California
University of California, San Francisco, Dept of Otolaryngology-HNS	Recruiting
San Francisco, California, United States, 94143
Contact: Wendy Ma 415-353-2870 wma@ohns.ucsf.edu
Contact: Andrew Murr, MD 415-353-2870 ahmurr@ohns.ucsf.edu
Principal Investigator: Andrew Murr, MD
Sub-Investigator: Andrew Goldberg, MD, MSCE

Sponsors and Collaborators

University of California, San Francisco

Environmental Protection Agency (EPA)

Investigators

Principal Investigator:

Andrew Murr, MD

University of California, San Francisco

More Information

Publications:

Catten MD, Murr AH, Goldstein JA, Mhatre AN, Lalwani AK. Detection of fungi in the nasal mucosa using polymerase chain reaction. Laryngoscope. 2001 Mar;111(3):399-403.

Scheuller MC, Murr AH, Goldberg AN, Mhatre AN, Lalwani AK. Quantitative analysis of fungal DNA in chronic rhinosinusitis. Laryngoscope. 2004 Mar;114(3):467-71.

Vesper SJ, Varma M, Wymer LJ, Dearborn DG, Sobolewski J, Haugland RA. Quantitative polymerase chain reaction analysis of fungi in dust from homes of infants who developed idiopathic pulmonary hemorrhaging. J Occup Environ Med. 2004 Jun;46(6):596-601.

Responsible Party:	University of California, San Francisco ( Andrew Murr, MD )
Study ID Numbers:	H9272-26987-04
Study First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739921
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

PCR Analysis
Allergic fungal sinusitis
Chronic rhinosinusitis
Nasal Polyps

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Otorhinolaryngologic Diseases
Polyps
Sinusitis
Nasal Polyps
Naphazoline
Tetracaine

Oxymetazoline
Respiratory Tract Diseases
Respiratory Tract Infections
Phenylephrine
Guaifenesin
Phenylpropanolamine

Additional relevant MeSH terms:

Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009