- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004638
Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children
June 23, 2005 updated by: National Center for Research Resources (NCRR)
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
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
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Sinusitis
-
LifeBridge HealthUnknownChronic Sinusitis | Nasal Polyps | Chronic Sinusitis, Ethmoidal | Chronic Sinusitis, Sphenoidal | Chronic Sinusitis - Frontoethmoidal | Chronic Sinusitis - Ethmoidal, Posterior | Chronic Sinusitis - Ethmoidal Anterior | Nasal Polyp - PosteriorUnited States
-
Loma Linda UniversityWithdrawnChronic Sinus Disease | Chronic Sinusitis, Ethmoidal | Chronic Sinusitis, Sphenoidal | Chronic Sinusitis - Maxillary Bilateral | Chronic Sinusitis - Frontoethmoidal
-
Assiut UniversityNot yet recruitingDeviated Nasal Septum Effect on Maxillary Sinus Volumes and Development of Maxillary Sinusitis by CTDeviated Nasal Septum and Maxillary Sinusitis
-
Tampere University HospitalRecruitingMaxillary Sinusitis | Eustachian Tube Dysfunction | Sinusitis, Chronic | Sinusitis RecurrentFinland
-
STS MedicalNot yet recruitingChronic Sinusitis, Ethmoidal
-
Collin County Ear Nose & ThroatIntersect ENTCompletedChronic Sinusitis, EthmoidalUnited States
-
Ayu, Inc.CompletedSinusitis | Rhinosinusitis | Chronic Rhino-sinusitisMalaysia
-
Deraya UniversityCompleted
-
St. Louis UniversityTerminatedStent | Sinusitis, FrontalUnited States
-
Shanghai Yidian Pharmaceutical Technology Development...RecruitingChronic Sinusitis Without Nasal PolypsChina
Clinical Trials on pathogenesis study
-
Li YangWest China HospitalRecruiting
-
University of FloridaHeermann Anesthesia FoundationActive, not recruitingAcute Kidney InjuryUnited States
-
National Taiwan University HospitalMackay Memorial Hospital; National Cheng-Kung University Hospital; Tri-Service... and other collaboratorsRecruitingMultisystem Inflammatory Syndrome in Children | COVID-19-Associated EncephalitisTaiwan
-
International Partnership for Microbicides, Inc.Completed
-
University of Illinois at ChicagoTerminatedNonalcoholic Steatohepatitis (NASH) | Hepatic SteatosisUnited States
-
Babu BalagopalJohns Hopkins University; GlaxoSmithKline; Thomas Jefferson UniversityCompleted
-
Gilead SciencesCompletedChronic HCV InfectionChina, Korea, Republic of, Taiwan
-
Gilead SciencesCompleted
-
University of LeedsCompleted
-
New Ismailia National UniversityCompleted