NCT00739921

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

8.9 years

First QC Date

August 19, 2008

Last Update Submit

December 2, 2019

Conditions

SinusitisNasal Polyps

Keywords

PCR AnalysisAllergic fungal sinusitisChronic rhinosinusitisNasal Polyps

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Patients with sinusitis compared to patients without. To find out if any specific type of fungus or mold is correlated with chronic sinus disease. The study will add new information about the different types of fungus and mold found in the human nose.

Procedure: Nasal swab under endoscopic guidance

Interventions

Nasal swab under endoscopic guidancePROCEDURE

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with no sinus disease and subjects with chronic rhinosinusitis.

You may not qualify if:

  • Immunocompromise
  • Pregnancy
  • Minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco, Dept of Otolaryngology-HNS

San Francisco, California, 94143, United States

Location

Related Publications (3)

  • 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. doi: 10.1097/00005537-200103000-00006.

    PMID: 11224767BACKGROUND

  • 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. doi: 10.1097/00005537-200403000-00015.

    PMID: 15091220BACKGROUND

  • 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. doi: 10.1097/01.jom.0000128160.17144.6e.

    PMID: 15213523BACKGROUND

MeSH Terms

Conditions

SinusitisNasal PolypsAllergic Fungal Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMycosesBacterial Infections and MycosesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andrew Murr, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 22, 2008

Study Start

June 1, 2006

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

US(1)