Clinical Study to Improve Diagnosis and Treatment of Sinusitis

NCT ID: NCT00962689

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-11-30

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.

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."

Conditions

Chronic Sinusitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Rhinosinusitis

Patients with chronic rhinosinusitis as defined by American Academy of Otolaryngology-Head and Neck Surgery and American Rhinologic Society guidelines

No interventions assigned to this group

Control Group

Patients undergoing endoscopic sinus surgery for diseases other than chronic rhinosinusitis (i.e., access to pituitary gland, etc)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subinoy Das, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18978510 (View on PubMed)

Other Identifiers

KL2RR025754

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009H0067

Identifier Type: -

Identifier Source: org_study_id