Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)NCT06892704
Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
An observational study of Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) and Smell Loss, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are: 1. Does obstruction of the olfactory cleft predict return of the sense of smell? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), Smell Loss
- What is being tested?
- Dupilumab - Standard Dose
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.
- Well documented history of CRSwNP
- BSIT age/sex classified as "abnormal" score
- Self-reported stable olfactory deficit of moderate to severe quality > 3 months
- Prior endoscopic sinus surgery >3 months, <10 years prior
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Aditi Agarwal, MBBS, MSCI, 312 6958182, aditi.agarwal@northwestern.edu
Bruce Tan, MD MS, 312 6958182, btan@nm.org
About this study
Official title: Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:
- Does obstruction of the olfactory cleft predict return of the sense of smell?
- Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?
Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.
- Being tested
- Dupilumab - Standard Dose
- Keywords
- Dupilumab, Chronic Rhinosinusitis with Nasal Polyps, Smell Loss, Electrophysiology
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab - Standard DoseDrug
24 weeks of dupilumab 300mg q2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab Treatment | Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab Receives: Drug: Dupilumab - Standard Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status change of the Brief Smell Identification Test
The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 May 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Bruce Tan, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892704
- Sponsor's protocol ID
- STU00222296
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
- ClinicalTrials.gov ID
- NCT06892704
- Acronym / sponsor ID
- STU00222296
- Keywords
- Dupilumab, Chronic Rhinosinusitis with Nasal Polyps, Smell Loss, Electrophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Mar 2025 (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.
The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:
- Does obstruction of the olfactory cleft predict return of the sense of smell?
- Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?
Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab Treatment | – | Drug: Dupilumab - Standard DosePatients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.
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 |
|---|---|---|
| Dupilumab - Standard Dose24 weeks of dupilumab 300mg q2 weeks | Drug | Dupilumab Treatment |
Primary outcome
Status change of the Brief Smell Identification Test
Time frame: 26 weeks
The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.
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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD underlying publication
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.
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 Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) and Smell Loss, run by Northwestern University 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?
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 16 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 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?
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 Clinical Coordinator (312 6958182, aditi.agarwal@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status change of the Brief Smell Identification Test (time frame: 26 weeks). 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 16 Jul 2026.