Skip to main content
OpenTrials
Completed

NCT Number: NCT03250429

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sinusitis, Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Organizing Pneumonia Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinus surgery

Procedure

Standard Clinical Sinus Surgery

Primary outcomes

  1. Change in Inflammatory mediators in the nasal mucosa

    Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

    Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to Transforming growth factor beta 1 (TGFβ1), Interferon gamma (IFNγ), Interleukin 5 (IL-5), Interleukin 17 (IL-17), eosinophil cationic protein (ECP), mast cell tryptase, and Interleukin (IL-10) from the nasal mucosa.

Secondary outcomes

  1. Change in Inflammatory mediators in the peripheral blood

    Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

    Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to TGFβ1, IFNγ, IL-5, IL-17, ECP, mast cell tryptase, and IL-10 from the peripheral blood.

  2. Change in Rhinosinusitis Disability Index (RSDI) Scores

    Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

    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.

  3. Change in gene expression profile

    Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

    Analyze cells for gene expression of inflammatory mediators including but not limited to TGFβ1, IFNγ, IL-5, IL-17, ECP, mast cell tryptase, and IL-10

  4. Change in Nasal lavage fluid cell count

    Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

    Count cell types present in nasal lavage fluid cells.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Flight Attendant Medical Research Institute

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.