Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 23, 2000

First Submitted That Met QC Criteria

February 23, 2000

First Posted (Estimate)

February 24, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2001

More Information

Terms related to this study

Other Study ID Numbers

  • NCRR-M01RR00069-0609
  • M01RR000069 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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