Clinical Study to Improve Diagnosis and Treatment of Sinusitis

NCT00962689 | Completed

• 2 other identifiers: 2009H0067KL2RR025754
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Sinusitis

Keywords

chronic rhinosinusitis; biofilm; sinus tissue; nasal secretions; proteomics; diagnosis; decreased antibiotics; Develop a test to identify patients with sinusitis subtypes

Study Arms (2)

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)

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from age 5 to 90 undergoing endoscopic sinus surgery for treatment of chronic rhinosinusitis

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Das S, Maeso PA, Becker AM, Prosser JD, Adam BL, Kountakis SE. Proteomics blood testing to distinguish chronic rhinosinusitis subtypes. Laryngoscope. 2008 Dec;118(12):2231-4. doi: 10.1097/MLG.0b013e318182f7f4.

  PMID: 18978510 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood nasal secretions nasal mucosa nasal polyps

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Subinoy Das, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)