Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 2/2/2019 |
| Start Date: | September 1, 2017 |
| End Date: | December 2019 |
To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS)
before and after sinus surgery.
before and after sinus surgery.
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.
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.
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Ilona Jaspers, PhD
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