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NCT00004638 Clinical Trial

Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

Sinusitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004638
Other study ID # NCRR-M01RR00069-0609
Secondary ID M01RR000069
Status Completed
Phase N/A
First received February 23, 2000
Last updated June 23, 2005

Study information
Verified date November 2001
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• pathogenesis study

Locations
Country Name City State
United States The Children's Hospital Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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