Clinical Study to Improve Diagnosis and Treatment of Sinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Ohio State University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Subinoy Das, Ohio State University
ClinicalTrials.gov Identifier:
NCT00962689
First received: August 19, 2009
Last updated: October 14, 2013
Last verified: October 2013
  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


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   5 Years to 90 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962689

Contacts
Contact: Subinoy Das, MD (614) 293-8310 subinoydas@yahoo.com
Contact: Melanie Clark (614) 293-8310 melanie.clark@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Subinoy Das, MD    614-293-8310    subinoydas@yahoo.com   
Contact: Melanie Clark    (614) 293-8310    melanie.clark@osumc.edu   
Principal Investigator: Subinoy Das, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Subinoy Das, MD    614-293-8310    subinoydas@yahoo.com   
Principal Investigator: Subinoy Das, MD         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Subinoy Das, MD Ohio State University
  More Information

Publications:
Responsible Party: Subinoy Das, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00962689     History of Changes
Other Study ID Numbers: 2009H0067, KL2RR025754
Study First Received: August 19, 2009
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

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
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014