Clinical trial NCT03250429: Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
Official title: Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis, Chronic
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Flight Attendant Medical Research Institute
First posted: 2017-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are patients at UNC Healthcare ENT clinics

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Inflammatory mediators in the nasal mucosa
timeFrame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary outcomes:
measure: Change in Inflammatory mediators in the peripheral blood
timeFrame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
measure: Change in Rhinosinusitis Disability Index (RSDI) Scores
timeFrame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
measure: Change in gene expression profile
timeFrame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
measure: Change in Nasal lavage fluid cell count
timeFrame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: UNC SOM
name: Ilona Jaspers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: