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Clinical Study to Improve Diagnosis and Treatment of Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962689
First Posted: August 20, 2009
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Ohio State University
  Purpose
Chronic rhinosinusitis (CRS) is the most common chronic medical condition that affects Americans between 18-44 years of age. While significant advances have been made in the understanding of the molecular pathogenesis underlying many subtypes of CRS, this has not translated into widespread changes in how physicians manage adult or pediatric CRS. The focus of this study is intended to develop testing methods to improve the objectivity and specificity of diagnosis and allow for individualized therapy with less invasive, customized treatments instead of the traditional, empiric based, and radically exenterative therapies commonly employed in clinical practice. Specifically, it is now known that many patients with CRS have a greater concentration of non-typeable Haemophilus influenzae (NTHI) in the bacterial biofilms located within their sinus cavities compared to healthy patients. The specific hypothesis behind the proposed research is that the presence of NTHI biofilms, which are known to be highly recalcitrant, are positively correlated with the development of CRS and that unique lipooligosaccharides and inflammatory byproducts obtained from nasopharyngeal lavage fluids and/or swabs of sinus secretions may be used as a non-invasive biomarker for CRS. As a result, patients with symptoms of CRS specifically associated with NTHI biofilms could possibly obtain a non-invasive test in the physician's office that would allow the clinician to make a more accurate diagnosis and objectively follow each patient's responsiveness to customized therapy.

Condition
Chronic Sinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Patient Care Via Proteomics Based, Microbe-Specific Detection of Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Biospecimen Retention:   Samples With DNA
whole blood nasal secretions nasal mucosa nasal polyps

Enrollment: 38
Actual Study Start Date: August 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Rhinosinusitis
Patients with chronic rhinosinusitis as defined by American Academy of Otolaryngology-Head and Neck Surgery and American Rhinologic Society guidelines
Control Group
Patients undergoing endoscopic sinus surgery for diseases other than chronic rhinosinusitis (i.e., access to pituitary gland, etc)

Detailed Description:

Specific Aims:

Specific Aim 1 will test the hypothesis that a high throughput proteomics-based assay of nasopharyngeal lavage fluids and/or swabs of human sinus drainage material will be able to identify, with a high degree of sensitivity and specificity, patients with CRS specifically due to the presence of NTHI biofilms.

Specific Aim 2 will test the hypothesis that a priori assay for increased presence of phosphorylcholine-rich lipooligosaccharides in nasopharyngeal lavage fluids from chinchillas co-infected with adenovirus and biofilm forming NTHI will successfully predict, with a high degree of sensitivity and specificity, the development of CRS in this in vivo model.

Results from this project may: enable the design and conduct of a clinical trial to preoperatively identify patients with CRS earlier in their disease course (possibly prior to the initiation of long courses of empiric antibiotic therapy); aid in the development of non-surgical therapies to eradicate bacterial biofilms with the sinus cavities; result in the identification of an objective biomarker to monitor success with therapies; and ultimately lead to less morbidity and risk for complications compared to conventional surgical therapy. In addition, transforming this paradigm would make progress towards achieving the goals of the U.S. Department Health and Human Services Healthy People 2010 objective 14-19, which is "reducing the number of courses of antibiotics prescribed for the sole diagnosis of the common cold."

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from age 5 to 90 undergoing endoscopic sinus surgery for treatment of chronic rhinosinusitis
Criteria

Inclusion Criteria:

  • Clinical diagnosis of chronic sinusitis
  • Undergoing surgery for treatment of their disease

Exclusion Criteria:

  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): NCT00962689


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Subinoy Das, MD Ohio State University
  More Information

Publications:
Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT00962689     History of Changes
Other Study ID Numbers: 2009H0067
KL2RR025754 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2009
First Posted: August 20, 2009
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ohio State University:
chronic rhinosinusitis
biofilm
sinus tissue
nasal secretions
proteomics
diagnosis
decreased antibiotics
Develop a test to identify patients with sinusitis subtypes

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