Sinusitis, ChronicNCT03250429
Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
An observational study of Sinusitis, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sinusitis, Chronic
- What is being tested?
- Sinus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects who are patients at UNC Healthcare ENT clinics
Who may be able to join
- Physician diagnosed CRS with surgical requirement for treatment
Who cannot join
- Subjects with physician-diagnosed:
- cystic fibrosis,
- vasculitis,
- any type of nasal tumor
- receiving ongoing immunosuppressant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.
Read the 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.
- Conditions
- Sinusitis, Chronic
- Being tested
- Sinus surgery
- Medical subject headings
- Sinusitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus surgeryProcedure or surgery
Standard Clinical Sinus Surgery
| Study group | Role | What they receive |
|---|---|---|
| CRS subjects | CRS subjects who have sinus surgery Receives: Procedure: Sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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.
Measured: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Secondary outcomes (4)
Change in Inflammatory mediators in the peripheral blood
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.
Measured: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
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.
Measured: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Change in gene expression profile
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
Measured: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Change in Nasal lavage fluid cell count
Count cell types present in nasal lavage fluid cells.
Measured: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017
- Primary completion10 Dec 2018
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinusitis, ChronicStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Ilona Jaspers, Ph.D., Principal investigator, UNC SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250429
- Sponsor's protocol ID
- 17-1499
- Status last verified
- Feb 2020
- First submitted
- 10 Aug 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
- ClinicalTrials.gov ID
- NCT03250429
- Acronym / sponsor ID
- 17-1499
- Conditions
- Sinusitis, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS subjects | – | Procedure: Sinus surgeryCRS subjects who have sinus surgery |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects who are patients at UNC Healthcare ENT clinics
Key inclusion criteria (1 listed)
- Physician diagnosed CRS with surgical requirement for treatment
Key exclusion criteria (5 listed)
- Subjects with physician-diagnosed:
- cystic fibrosis,
- vasculitis,
- any type of nasal tumor
- receiving ongoing immunosuppressant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus surgeryStandard Clinical Sinus Surgery | Procedure or surgery | CRS subjects |
Primary outcome
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.
4 secondary outcomes
Change in Inflammatory mediators in the peripheral blood
Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Change in Rhinosinusitis Disability Index (RSDI) Scores
Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Change in gene expression profile
Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Change in Nasal lavage fluid cell count
Time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilona Jaspers, Ph.D. principal investigator
UNC SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, Chronic, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory mediators in the nasal mucosa (time frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.