Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT04869436
Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
A Phase 4 study testing Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] in people with Chronic Rhinosinusitis With Nasal Polyps and Olfactory Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Olfactory Disorder
- What is being tested?
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jul 2021to 16 Sep 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Chronic rhinosinusitis with Nasal Polyps
- Olfactory loss
- Clinical indication for treatment with Dupilumab
Who cannot join
- Patients with olfactory loss from other causes such as:
- Sinonasal malignancies
- Trauma
- Idiopathic olfactory loss
- Use of cocaine
- COVID-19 related olfactory loss
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).
The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
- Being tested
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Drug
Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab group | Experimental | Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months. Receives: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.
Measured: Baseline, 12 weeks and 24 weeks.
Secondary outcomes (3)
Change from Baseline in the Nasal Polyps score at weeks 12 and 24.
Nasal Polyps score is the sum of the right and left nostril scores (endoscopic assessment). Total score ranges from 0 (no polyps) to 8 (large polyps on for each nostril [4+4] ).
Measured: Baseline, 12 weeks and 24 weeks.
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.
SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis on patients' quality of life. Patient grades the impact of 22 potential symptoms in their life, by choosing from 0 [no problem] to 5 [problem as bad as it can be]. Highest possible score is 10 (worst quality of life); minimal clinically important change ≥ 8.90
Measured: Baseline, 12 weeks and 24 weeks.
Change from Baseline in the QOD-NS at weeks 12 and 24.
Quality of Olfactory Disorders - negative symptoms (questionnaire)
Measured: Baseline, 12 weeks and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start19 Jul 2021
- Primary completion1 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group 6 months treatment with Dupilumab.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Principal investigator, Leigh Sowerby, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Leigh J Sowerby, MD, FRCS, Principal investigator, St. Joseph's Hospital London, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869436
- Sponsor's protocol ID
- 3618
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab
- ClinicalTrials.gov ID
- NCT04869436
- Acronym / sponsor ID
- 3618
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 3 May 2021 (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 study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).
The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group 6 months treatment with Dupilumab.
| Arm | Type | Receives |
|---|---|---|
| Dupilumab group | Experimental | Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years old
- Chronic rhinosinusitis with Nasal Polyps
- Olfactory loss
- Clinical indication for treatment with Dupilumab
Key exclusion criteria (7 listed)
- Sinonasal malignancies
- Trauma
- Idiopathic olfactory loss
- Use of cocaine
- COVID-19 related olfactory loss
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 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks) | Drug | Dupilumab group |
Primary outcome
Change from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24.
Time frame: Baseline, 12 weeks and 24 weeks.
The Sniffin' Sticks test involves testing odor for threshold and discrimination whilst blind folded and secondly odor identification. The sum of four odors responses ranges from 0-16. The sum of total score from odor Threshold, Discrimination and Identification (TDI) is a maximum of 48 points. The total score is graded as; normosmia equals or over 30.5 points, hyposmia 16.5-30 points and anosmia less than 16.5 points.
3 secondary outcomes
Change from Baseline in the Nasal Polyps score at weeks 12 and 24.
Time frame: Baseline, 12 weeks and 24 weeks.
Change from Baseline in the Sino-nasal outcome test- 22 (SNOT-22) at weeks 12 and 24.
Time frame: Baseline, 12 weeks and 24 weeks.
Change from Baseline in the QOD-NS at weeks 12 and 24.
Time frame: Baseline, 12 weeks and 24 weeks.
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 22 Sep 2026.
- Individual participant dataSharing planned: No. No plan to make IPD available.
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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.
Leigh J Sowerby, MD, FRCS principal investigator
St. Joseph's Hospital London, ON, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] in people with Chronic Rhinosinusitis With Nasal Polyps and Olfactory Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 4 inclusion and 7 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 22 Sep 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from Baseline in the Smell Threshold, Identification and Discrimination (TDI score) at week 12 and week 24. (time frame: Baseline, 12 weeks and 24 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 22 Sep 2026.