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Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

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ClinicalTrials.gov Identifier: NCT00004638
Recruitment Status : Completed
First Posted : February 24, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment
Sinusitis Procedure: pathogenesis study

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004638


Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information

ClinicalTrials.gov Identifier: NCT00004638     History of Changes
Other Study ID Numbers: NCRR-M01RR00069-0609
M01RR000069 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

Keywords provided by National Center for Research Resources (NCRR):
chronic sinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases