Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention

Sinusitis, Chronic Clinical Trial

Official title:

Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250429
• Other study ID #: 17-1499
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.

Description:

Rhinosinusitis (RS) is a heterogenous disease, with variable etiologies, manifestations, and progression. Generally, RS can be divided into acute, subacute, and chronic RS, depending on the symptoms and duration of the disease. Most commonly, acute RS is caused by a viral infection (viral RS), which starts in the nasal passages and progresses to inflammation of the sinuses. When this inflammation of the paranasal sinuses does not resolve and lasts for at least 12 weeks, the disorder is broadly defined as chronic RS (CRS), which is usually accompanied by bacterial infections. This inflammatory disease pathophysiology is further subdivided into CRS with (CRSwNP) and without (CRSsNP) nasal polyps. Recently, several studies aimed at phenotyping the diverse pathophysiology among patients suffering from CRS characterized subgroups based on the presence of inflammatory clusters. CRSsNP is marked by pro-inflammatory neutrophilic inflammation of the nasal mucosa and a nasal cytokine profile that is characterized by increased levels of TGFβ1 and IFNγ and low or undetectable levels of IL-5. In contrast, patients with CRSwNP demonstrate eosinophilic inflammation of the nasal mucosa, low levels of TGFβ1, but high levels of Th2/Th17-type cytokines such as IL-17 and IL-5, higher levels of eosinophil cationic protein (ECP) and mast cell tryptase, and lower levels of IL-10.

Currently biomarkers associated with physician diagnosed disease severity and patient-perceived quality of life impairments are lacking. Analysis of markers of inflammation in the nasal mucosa and peripheral blood leukocytes in combination with quality of life symptom scoring will enable us to identify biomarkers associated with CRS disease severity. This study will determine if biomarkers identified in the nasal mucosa and peripheral blood leukocytes correlate with physician diagnosed and patient-perceived disease severity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Physician diagnosed CRS with surgical requirement for treatment

Exclusion Criteria:

• Subjects with physician-diagnosed:

• cystic fibrosis,

• vasculitis,

• any type of nasal tumor

• receiving ongoing immunosuppressant therapy

Related Conditions & MeSH terms

• Sinusitis
• Sinusitis, Chronic

Intervention

Procedure:
• Sinus surgery
Standard Clinical Sinus Surgery

Locations

Country	Name	City	State
United States	Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Flight Attendant Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inflammatory mediators in the nasal mucosa	Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to Transforming growth factor beta 1 (TGFß1), Interferon gamma (IFN?), Interleukin 5 (IL-5), Interleukin 17 (IL-17), eosinophil cationic protein (ECP), mast cell tryptase, and Interleukin (IL-10) from the nasal mucosa.	Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary	Change in Inflammatory mediators in the peripheral blood	Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to TGFß1, IFN?, IL-5, IL-17, ECP, mast cell tryptase, and IL-10 from the peripheral blood.	Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary	Change in Rhinosinusitis Disability Index (RSDI) Scores	The RSDI is a disease-specific health-related quality of life instrument with 3 domains (physical, functional, and emotional impacts of rhinosinusitis) using a 5-point Likert scale ranging from 0 to 4 where 0 is "never" and 4 is "always a problem". Higher scores indicate more significant impact on quality of life.	Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary	Change in gene expression profile	Analyze cells for gene expression of inflammatory mediators including but not limited to TGFß1, IFN?, IL-5, IL-17, ECP, mast cell tryptase, and IL-10	Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary	Change in Nasal lavage fluid cell count	Count cell types present in nasal lavage fluid cells.	Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)