An observational study in CRSwNP or CRSsNP Patients, sponsored by AstraZeneca. Recruiting at 4 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by AstraZeneca · Observational
Given the high variability in the inflammatory profiles of CRSwNP (Chronic rhinosinusitis with nasal polyps) patients that influence both disease phenotype and response to treatment, exploring further potential targets is crucial for advancing novel biologic treatment strategies. By indicating the efficacy of targeted therapy, as well as determining clinical features, endotyping of CRSwNP may offer a useful tool to better tailor treatment approaches in this heterogenous patient population. This study is the first national effort to collect data on inflammatory markers and burden of CRSwNP patients in Greece aiming at identifying disease endotypes based on patients' inflammatory profile.
A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights. Patients who discontinue should be asked about the reason(s) for their discontinuation. If the participant withdraws consent for disclosure of future information, AstraZeneca may retain and continue to use any data collected before such a withdrawal of consent
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CRSwNP patients who are scheduled to undergo first ESS (prospective patients) will be recruited from approximately 6 Ear-Nose-Throat (ENT) and 1 pulmonology clinics. Moreover, CRSwNP and CRSsNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples (retrospective patients) will be recruited from 1 ENT clinic.
Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:
If CRSsNP group:
Diagnosis of CRSsNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines
Patients receiving any standard of care treatment for CRSwNP, provided the participant is stable on that treatment for ≥30 days
Exclusion Criteria:
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
Other: Not applicable - NIS study
CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
Other: Not applicable - NIS study
CRSsNP (Chronic rhinosinusitis without nasal polyps) patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
Other: Not applicable - NIS study
Not applicable - NIS study
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
Time frame: At Visit 1 (day 1)
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
Time frame: At Visit 1 (day 1)
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
Eosinophil and neutrophil cell counts will be recorded, as per the EPOS 2020, eosinophilia is defined as \>10 eosinophils/hpf.
Time frame: At Visit 1 (day 1)
Characterization of nasal histological alterations in retrospective patients with CRSwNP
Tissue morphology and potential tissue destruction and nasal epithelium remodeling by standard histology staining (e.g. hematoxylin and eosin, Periodic Acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
Time frame: At Visit 1 (day 1)
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Demographics at study entry/screening (age, sex, ethnicity, smoking status, cigarettes/day/year, alcohol status (units/week), body measurements (BMI kg/m2), employment status, educational level, residence area) will be recorded
Time frame: Up to 24 ± 2 months (through study completion)
1i. Description of medical history of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Patients' medical history, including the date of first and severe CRSwNP diagnosis, comorbidities, and disease management \[use (yes/no) of saline, systemic/local glucocorticoids, biologics, antibiotics\], will be reported at the time of enrolment and during 24 months after first ESS.
Time frame: Up to 24 ± 2 months (through study completion)
1i. Description of first ESS characteristics in CRSwNP patients
Time to first ESS from CRSwNP diagnosis and from severe CRSwNP diagnosis will be assessed
Time frame: At Visit 1 (day 1)
1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
The 22-item Sinonasal Outcome Test (SNOT-22), which is a health-related quality of life (HRQoL) evaluation with each item scored on a Likert scale ranging from 0 "No problem" to 5 "Problem as bad as it can be".
Time frame: Up to 24 ± 2 months (through study completion)
1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
The Nasal Polyposis Symptom Diary (NPSD), which is a short patient-reported outcome (PRO) tool comprising 11 items (8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance). The Total Symptom Score (TSS) is a summary of the first 8 symptom-specific items, scored on a 4-point scale \[0-none, 1-mild, 2-moderate, 3-severe\], with a resulting score from 0 to 24
Time frame: Up to 24 ± 2 months (through study completion)
1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma)
The Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma that includes 5 items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The ACT responses for each of the items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
Time frame: Up to 24 ± 2 months (through study completion)
1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
NPS is a physician-reported tool that grades the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 - "No nasal polyps" to 4 - "Large nasal polyps causing complete obstruction of the inferior nasal cavity", with the total score being the sum of left and right nostril scores (range: 0-8).
Time frame: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
1iii. Assessment of imaging results in CRSwNP patients
The Lund-Mackay (LM) CT score that evaluates sinus opacification on CT scans. This score ranges from 0 -"complete lucency of all sinuses" to 24 - "complete opacity of all sinuses"
Time frame: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
2. Characterization of blood cytokines/chemokines in prospective patients with CRSwNP
Cytokine/chemokine analysis of blood samples following first ESS will be performed by Luminex and ELISA analysis
Time frame: At Visit 1 (day 1)
2. Characterization of blood immune cell populations in prospective patients with CRSwNP
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
Time frame: At Visit 1 (day 1)
2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP
Serum immunoglobulin levels \[total IgE, specific IgE to staphylococcal enterotoxins (SE-IgE)\]
Time frame: At Visit 1 (day 1)
2. Characterization of WBC count in prospective patients with CRSwNP
Differential WBC count (incl. absolute count) will be recorded
Time frame: At Visit 1 (day 1)
2. Characterization of RBC count in prospective patients with CRSwNP
RBC count will be recorded
Time frame: At Visit 1 (day 1)
3. Association of time to CRSwNP recurrence and CRSwNP endotypes over 24 months following first ESS in CRSwNP patients
The number of CRSwNP recurrences along with the date(s) of recurrence(s) will be recorded in the eCRF by the investigator at 24 months following first ESS for CRSwNP patients (including retrospective CRSwNP patients, if data are available). The time to relapse during the 24-month follow-up will be also estimated.
Time frame: Up to 24 ± 2 months (through study completion)
4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
Endotypes of CRSsNP patients who have performed first ESS in the period between 2012 and enrolment (retrospective patients) will be determined based on cytokine/chemokine analysis of frozen extracted nasal tissue from ESS, including Fractalkine, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, (p70), IL-13, IL-17A, IL-21, IL-23, ITAC, MIP-1α, MIP-1β, MIP-3α, TNF-α, TSLP, IL-9, IL-33, IL-17E/IL-25, TGFb1, IL-22
Time frame: At Visit 1 (day 1)
4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
Eosinophil and neutrophil cell counts will be recorded. As per the EPOS 2020, eosinophilia is defined as \>10 eosinophils/hpf
Time frame: At Visit 1 (day 1)
4. Differences in nasal tissue alterations between retrospective patients with CRSwNP and CRSsNP
tissue morphology and potential nasal tissue destruction and remodeling by standard histology staining (e.g. Hematoxylin and eosin, Periodic acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks. Depending on the nature of tissue pathology, further immunohistochemical analysis will be performed with the use of specific antibodies, such as markers for epithelial barrier integrity (e.g. E-cadherin or Cytokeratin), tissue remodeling (e.g. MMP-9) or chronic damage monitored by fibrosis (e.g. α-SMA or collagen)
Time frame: At Visit 1 (day 1)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol
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