Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

NCT ID: NCT00004638

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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Conditions

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Sinusitis

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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pathogenesis study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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The Children's Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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M01RR000069

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00069-0609

Identifier Type: -

Identifier Source: org_study_id