CRSwNP or CRSsNP PatientsDEBATENCT07663409
The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP"
An observational study of CRSwNP or CRSsNP Patients, run by AstraZeneca at 4 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRSwNP or CRSsNP Patients
- What is being tested?
- Not applicable - NIS study
- How many people
- 230 participants
- Where
- 4 sitesGreece
- Study dates
- 29 Jun 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- If CRSwNP group:
- Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:
- CRSwNP severity consistent with the need for surgery as defined by a total nasal polyp score (NPS) of ≥5 (≥2 for each nostril)
- Nasal Congestion Score (NCS) of ≥2
- Ongoing documented symptoms of CRSwNP for > 8 weeks before surgery
Show all 13Show fewer
- If CRSsNP group:
- Diagnosis of CRSsNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines
- Have performed in the period between 2012 and enrolment or are scheduled to perform endoscopic sinus surgery (ESS) for the first time at enrolment
- Have available nasal polyp tissue sample from the first endoscopic sinus surgery (ESS)
- Have provided signed and dated written informed consent
- If CRSwNP group:
- Patients receiving any standard of care treatment for CRSwNP, provided the participant is stable on that treatment for ≥30 days
Who cannot join
- Patients with cystic fibrosis or immunodeficiency
- Presence of acute exacerbation of CRS symptoms within 2 weeks prior to surgery
- Use of systemic corticosteroids within 30 days prior to surgery, or antileukotrienes within 15 days prior to surgery, or biologic therapy prior to surgery
- Not adequate amount (<0.15g) or quality (e.g. storage temperature, contamination) of tissue sample for analyses
- Not available blood (serum) sample, only for patients scheduled to perform endoscopic sinus surgery (ESS) for the first time at the date of enrolment, for analyses.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
Greece4 sites, 4 recruiting
- Recruiting
Research Site
Alexandroupoli
- Not yet recruiting
Research Site
Athens
- Not yet recruiting
Research Site
Heraklion
- Not yet recruiting
Research Site
Thessaloniki
About this study
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.
Read the detailed description
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
- Conditions
- CRSwNP or CRSsNP Patients
- Being tested
- Not applicable - NIS study
- Keywords
- CRSwNP, CRSsNP, endotypes, inflammatory pathways
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - NIS studyOther
Not applicable - NIS study
| Study group | Role | What they receive |
|---|---|---|
| Prospective (CRSwNP) | CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery) Receives: Other: Not applicable - NIS study | |
| Retrospective (CRSwNP) | CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples Receives: Other: Not applicable - NIS study | |
| Retrospective (CRSsNP) | 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 Receives: Other: Not applicable - NIS study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Visit 1 (day 1)
Secondary outcomes (17)
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
Measured: 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.
Measured: 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
Measured: 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".
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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"
Measured: 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
Measured: 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.
Measured: 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)]
Measured: At Visit 1 (day 1)
2. Characterization of WBC count in prospective patients with CRSwNP
Differential WBC count (incl. absolute count) will be recorded
Measured: At Visit 1 (day 1)
2. Characterization of RBC count in prospective patients with CRSwNP
RBC count will be recorded
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: At Visit 1 (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start29 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRSwNP or CRSsNP PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cross-sectional
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663409
- Sponsor's protocol ID
- D5242R00007
- Acronym
- DEBATE
- Status last verified
- Apr 2026
- First submitted
- 18 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP"
- ClinicalTrials.gov ID
- NCT07663409
- Acronym / sponsor ID
- DEBATE / D5242R00007
- Conditions
- CRSwNP or CRSsNP Patients
- Keywords
- CRSwNP, CRSsNP, endotypes, inflammatory pathways
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Jun 2026 (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.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective (CRSwNP) | – | Other: Not applicable - NIS studyCRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery) |
| Retrospective (CRSwNP) | – | Other: Not applicable - NIS studyCRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples |
| Retrospective (CRSsNP) | – | Other: Not applicable - NIS studyCRSsNP (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- If CRSwNP group:
- Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:
- CRSwNP severity consistent with the need for surgery as defined by a total nasal polyp score (NPS) of ≥5 (≥2 for each nostril)
- Nasal Congestion Score (NCS) of ≥2
Key exclusion criteria (5 listed)
- Patients with cystic fibrosis or immunodeficiency
- Presence of acute exacerbation of CRS symptoms within 2 weeks prior to surgery
- Use of systemic corticosteroids within 30 days prior to surgery, or antileukotrienes within 15 days prior to surgery, or biologic therapy prior to surgery
- Not adequate amount (<0.15g) or quality (e.g. storage temperature, contamination) of tissue sample for analyses
- Not available blood (serum) sample, only for patients scheduled to perform endoscopic sinus surgery (ESS) for the first time at the date of enrolment, for analyses.
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 |
|---|---|---|
| Not applicable - NIS studyNot applicable - NIS study | Other | Prospective (CRSwNP), Retrospective (CRSsNP), Retrospective (CRSwNP) |
Primary outcome
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Time frame: At Visit 1 (day 1)
Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
Time frame: At Visit 1 (day 1)
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.
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
Time frame: At Visit 1 (day 1)
Eosinophil and neutrophil cell counts will be recorded, as per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf.
Characterization of nasal histological alterations in retrospective patients with CRSwNP
Time frame: At Visit 1 (day 1)
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.
17 secondary outcomes
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
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)
Time frame: Up to 24 ± 2 months (through study completion)
1i. Description of first ESS characteristics in CRSwNP patients
Time frame: At Visit 1 (day 1)
1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
Time frame: Up to 24 ± 2 months (through study completion)
1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
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)
Time frame: Up to 24 ± 2 months (through study completion)
1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
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
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
Time frame: At Visit 1 (day 1)
2. Characterization of blood immune cell populations in prospective patients with CRSwNP
Time frame: At Visit 1 (day 1)
2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP
Time frame: At Visit 1 (day 1)
2. Characterization of WBC count in prospective patients with CRSwNP
Time frame: At Visit 1 (day 1)
2. Characterization of RBC count in prospective patients with CRSwNP
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
Time frame: Up to 24 ± 2 months (through study completion)
4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
Time frame: At Visit 1 (day 1)
4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
Time frame: At Visit 1 (day 1)
4. Differences in nasal tissue alterations between retrospective patients with CRSwNP and CRSsNP
Time frame: At Visit 1 (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: 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.
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.
AstraZeneca Clinical Study Information Center contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRSwNP or CRSsNP Patients, run by AstraZeneca at 4 sites in Greece.
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 13 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP (time frame: At Visit 1 (day 1)). The study lists 4 primary outcomes in all. 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 22 Jul 2026.