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Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pathogenesis study
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sinusitis focused on measuring chronic sinusitis

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy

Sites / Locations

  • The Children's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 23, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00004638
Brief Title
Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief Summary
Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious diseases of the upper respiratory tract. Its treatment is limited and may be due largely in part to a lack of understanding of its cause. The investigators have preliminary data to support the notion that pediatric chronic sinusitis is a distinct disease, different from acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic features and immunologic factors involved in the formation of this disease. The study plan calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis (negative control) and 5 adults with chronic sinusitis (positive secondary control).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
chronic sinusitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
pathogenesis study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States

12. IPD Sharing Statement

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Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

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