Chronic Rhinosinusitis With Nasal PolypsPhase 4TORNADONCT05942222
A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
A Phase 4 study testing dupilumab and mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma; Eosinophilic, run by Copenhagen University Hospital, Rigshospitalet at 9 sites in Denmark.
Trial summary
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic, Eosinophilia
- What is being tested?
- dupilumab and mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 9 sitesDenmark
- Study dates
- 27 Apr 2023to 1 May 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Bilateral polyps in nose and sinuses
- ESS within the last three years (unless unfit for surgery y- in this study defined as either a severe somatic disease, for which other specialist advise against surgery, e.g., cardiac disease, pulmonary disease, or coagulation disorder OR/AND severe anxiety which can either be due to previous traumatic experiences with surgery or the postoperative period, post-traumatic stress disorder or severe anxiety disorder. In cases of doubt, investigators can ask for a written statement from the general practitioner or a psychiatrists/psychologist))
- Optimal local treatment with saline irrigation and topical nasal steroids for at least three months (unless contraindicated)
- Evidence of type 2 inflammation
- Furthermore, patients must fulfil three out the following five criteria:
- Need for systemic corticosteroids (at least two courses/year OR long-term treatment >3 months) or contraindication to systemic steroids
Show all 11Show fewer
- Significantly impaired QoL (SNOT-22 score≥50)
- Significant LoS (SSIT-16 score 0-8)
- NPS ≥5 (with at least 2 on either side)
- Asthma diagnosis (requiring inhaled corticosteroid (ICS))
- Also: Age of 18 years or more and able to read and/or speak Danish
Who cannot join
- Systemic corticosteroid treatment within the last three months
- Endoscopic sinus surgery (ESS) within the last six months
- Non-adherent to medicine regimens
- Hypersensitivity to the active substance or any of the excipients in the two IMPs
- Not able to understand spoken and/or written Danish
- Participation-current or previous (within the last year)-in another investigational drug trial with monoclonal antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis.
Show all 10Show fewer
- Previous treatment failure with one of the IMPs for any indication (treatment failure is defined as failure to achieve the desired therapeutic outcome or effectively manage a condition within an expected timeframe)
- Eosinophilic blood cell count of ≥1.5x10^9cells/L (at baseline, i.e. before first injection)
- Pronounced fear of needles
- Pregnant or breastfeeding patients
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Aalborg Universitetssygehus Syd
Aalborg, 9000
Aarhus Universitetshospital Skejby
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Sydvestjysk Sygehus Esbjerg
Esbjerg, 6700
Regionshospitalet Gødstrup
Herning, 7400
Nordsjællands Hospital
Hillerød, 3400
Sjællands Universitetshospital Køge
Køge, 4600
Odense Universitetshospital
Odense, 5000
Sygehus Lillebælt Vejle
Vejle, 7100
About this study
Official title: Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients.
The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of:
Read more
- A subjective score (the SNOT-22)
- An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8))
Methods:
Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
Read the detailed description
Objectives:
- The primary objective is to
- establish non-inferiority of dupilumab versus mepolizumab, and if that is established, then
- test for possible superiority of dupilumab over mepolizumab in the following hierarchical order (SNOT-22 - Sniffin' Sticks 16 - NPS - ACQ
- The secondary objective is to explore any other relevant differences between mepolizumab and dupilumab in terms of frequency of AEs, need for rescue treatments, diversity in outcome based on endotype or comorbidity or other factors, that can lead to a patient-centred approach, when choosing treatment for CRSwNP.
Trial design:
A randomized, multi-center non-inferiority trial (phase IV RCT). The trial is unblinded.
Investigational medicinal products (IMPs) will be "off-the-shelf" and administered in EMA-approved dosages and -intervals.
Trial population:
The trial aims to include 220 patients with severe, uncontrolled CRSwNP (110 patients in each treatment group). The patients will be recruited from 9 different sites across Denmark. Treatment in Denmark is 100% subsidized by the state.
Methods:
Subjects fulfilling inclusion criteria will be randomized 1:1 to either dupilumab or mepolizumab. After 24 weeks a halfway evaluation will decide if subjects are to stay in their current treatment arm, or cross-over to the opposite arm.
By including 220 participants (effectively 176 participants after 20% drop-outs) the study will achieve a power of >95% to show non-inferiority of dupilumab to mepolizumab for both co-primary endpoints with the following criteria: Level of significance for both endpoints of a one-sided test, p<0.025 and including previously found standard deviation (SD) values 1.9 for NPS and 22 for SNOT-22, an expected superior effect of 0.7 for NPS and 7 on SNOT-22, a minimal clinically relevant difference (MCID) of 1 for NPS and 12 for SNOT-22, respectively.
Trial medication:
All trial medication will be "off the shelf" i.e. no special labelling. It will be provided by hospital pharmacies in accordance with GMP. The investigational medicinal products (IMPs) are dupilumab (Dupixent, Sanofi) and mepolizumab (Nucala, GSK). Dupilumab are administered as subcutaneous injections of 300 mg every two weeks in the first 24 weeks. If the DMC response criteria (table 2) are met after 24 weeks, the dosing interval will be increased to every four weeks, in accordance with previous research and DMC recommendations. Mepolizumab is administered subcutaneously as 100 mg sc. every four weeks. Patients will continue standard of care treatment of INCS and saline irrigation, unless contraindicated.
If rescue treatment is needed, a course of oral corticosteroids (Prednisolone) 37.5 mg once daily for 7 days will be given.
Trial schedule:
Planned first subject first visit May 2023
Planned last subject randomized February 2025
Planned last subject last visit:March 2026
End of trial March 2026
- Being tested
- dupilumab, mepolizumab
- Medical subject headings
- Pulmonary Eosinophilia, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabBiological
Also called Dupixent
Subcutaneus injections in standard doses, i.e. 300 mg s.c. every 2 weeks.
mepolizumabBiological
Also called Nucala
Subcutaneus injections in standard doses, i.e. 100 mg s.c. every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab week 0-24 300 mg/2 weeks | Active comparator | Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks Receives: Biological: dupilumab |
| Mepolizumab week 0-24 100 mg/4 weeks | Active comparator | Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks Receives: Biological: mepolizumab |
| Dupilumab week 24-48 300 mg/4 weeks | Active comparator | Increased dosage interval of Dupixent i.e. 300 mg s.c. every 4 weeks - for subjects on Dupixent who met the 24 weeks effect criteria Receives: Biological: dupilumab |
| Dupilumab week 24-48 300 mg/2 weeks | Active comparator | Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks but for subjects who have crossed over after 24 weeks due to unmet effect criteria. Receives: Biological: dupilumab |
| Mepolizumab week 24-48 100 mg/4 weeks | Active comparator | Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks but for subjects who have crossed-over after 24 weeks due to unmet effect criteria. Receives: Biological: mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-22
Sino-Nasal Outcome Test 22 - change in score since baseline is measured.
Measured: Week 24
NPS
Nasal Polyp Score (0-8): 0 is no polyps, 4 is polyps extending below inferior turbinate's lower border. Each side is scored. The change in score at week 24 since baseline is measured.
Measured: Week 24
Secondary outcomes (9)
SNOT-22
Sino-Nasal Outcome Test 22 - change in score since week 24 and week 0 if applicable
Measured: Week 48
NPS
Nasal Polyp Score (0-8): 0 is no polyps, 4 is polyps extending below inferior turbinate - lower border. Each side is scored. Change in score since week 24 and week 0 if applicable
Measured: Week 48
Smell score (Sniffin' Sticks Identification Test-16- SSIT-16)
Change since baseline in SSIT-16 (range 0-16, where 0-8 is anosmia)
Measured: Week 48
Asthma control (Asthma Control Questionnaire)
Proportion of patients with ACQ score > 0,5 indicating well-controlled asthma.
Measured: Week 48
Nasal Congestion Score (NCS)
Range 0-3. Change since baseline
Measured: Week 48
Visual Analogue Scale of: smell/asthma/Chronic rhinosinusitis/N-ERD
Change in VAS-score (range 0-10) since baseline
Measured: Week 48
Proportion meeting the evaluation criteria set by the DMC
The DMC criteria is available at medicinraadets website medicinraadet.dk
Measured: Week 48
Fraction of Nitrous Oxide in expired air (FeNO)
A score above 25 indicates eosinophilic inflammation.
Measured: Week 48
Proportion needing rescue treatment
A rescue treatment is defined as systemic oral corticoids or endoscopic sinus surgery.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start27 Apr 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
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 Copenhagen University Hospital, RigshospitaletThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Korsgaard Pedersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian Pedersen, MD, Principal investigator, Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, DenmarkChristian von Buchwald, Study director, Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942222
- Sponsor's protocol ID
- 2022-ENT-3
- Acronym
- TORNADO
- Status last verified
- Jun 2025
- First submitted
- 22 May 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients
- ClinicalTrials.gov ID
- NCT05942222
- Acronym / sponsor ID
- TORNADO / 2022-ENT-3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 12 Jul 2023 (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 randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients.
The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of:
- A subjective score (the SNOT-22)
- An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8))
Methods:
Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
Detailed description
Objectives:
- The primary objective is to
- establish non-inferiority of dupilumab versus mepolizumab, and if that is established, then
- test for possible superiority of dupilumab over mepolizumab in the following hierarchical order (SNOT-22 - Sniffin' Sticks 16 - NPS - ACQ
- The secondary objective is to explore any other relevant differences between mepolizumab and dupilumab in terms of frequency of AEs, need for rescue treatments, diversity in outcome based on endotype or comorbidity or other factors, that can lead to a patient-centred approach, when choosing treatment for CRSwNP.
Trial design:
A randomized, multi-center non-inferiority trial (phase IV RCT). The trial is unblinded.
Investigational medicinal products (IMPs) will be "off-the-shelf" and administered in EMA-approved dosages and -intervals.
Trial population:
The trial aims to include 220 patients with severe, uncontrolled CRSwNP (110 patients in each treatment group). The patients will be recruited from 9 different sites across Denmark. Treatment in Denmark is 100% subsidized by the state.
Methods:
Subjects fulfilling inclusion criteria will be randomized 1:1 to either dupilumab or mepolizumab. After 24 weeks a halfway evaluation will decide if subjects are to stay in their current treatment arm, or cross-over to the opposite arm.
By including 220 participants (effectively 176 participants after 20% drop-outs) the study will achieve a power of >95% to show non-inferiority of dupilumab to mepolizumab for both co-primary endpoints with the following criteria: Level of significance for both endpoints of a one-sided test, p<0.025 and including previously found standard deviation (SD) values 1.9 for NPS and 22 for SNOT-22, an expected superior effect of 0.7 for NPS and 7 on SNOT-22, a minimal clinically relevant difference (MCID) of 1 for NPS and 12 for SNOT-22, respectively.
Trial medication:
All trial medication will be "off the shelf" i.e. no special labelling. It will be provided by hospital pharmacies in accordance with GMP. The investigational medicinal products (IMPs) are dupilumab (Dupixent, Sanofi) and mepolizumab (Nucala, GSK). Dupilumab are administered as subcutaneous injections of 300 mg every two weeks in the first 24 weeks. If the DMC response criteria (table 2) are met after 24 weeks, the dosing interval will be increased to every four weeks, in accordance with previous research and DMC recommendations. Mepolizumab is administered subcutaneously as 100 mg sc. every four weeks. Patients will continue standard of care treatment of INCS and saline irrigation, unless contraindicated.
If rescue treatment is needed, a course of oral corticosteroids (Prednisolone) 37.5 mg once daily for 7 days will be given.
Trial schedule:
Planned first subject first visit May 2023
Planned last subject randomized February 2025
Planned last subject last visit:March 2026
End of trial March 2026
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dupilumab week 0-24 300 mg/2 weeks | Active comparator | Biological: dupilumabNormal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks |
| Mepolizumab week 0-24 100 mg/4 weeks | Active comparator | Biological: mepolizumabNormal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks |
| Dupilumab week 24-48 300 mg/4 weeks | Active comparator | Biological: dupilumabIncreased dosage interval of Dupixent i.e. 300 mg s.c. every 4 weeks - for subjects on Dupixent who met the 24 weeks effect criteria |
| Dupilumab week 24-48 300 mg/2 weeks | Active comparator | Biological: dupilumabNormal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks but for subjects who have crossed over after 24 weeks due to unmet effect criteria. |
| Mepolizumab week 24-48 100 mg/4 weeks | Active comparator | Biological: mepolizumabNormal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks but for subjects who have crossed-over after 24 weeks due to unmet effect criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Bilateral polyps in nose and sinuses
- ESS within the last three years (unless unfit for surgery y- in this study defined as either a severe somatic disease, for which other specialist advise against surgery, e.g., cardiac disease, pulmonary disease, or coagulation disorder OR/AND severe anxiety which can either be due to previous traumatic experiences with surgery or the postoperative period, post-traumatic stress disorder or severe anxiety disorder. In cases of doubt, investigators can ask for a written statement from the general practitioner or a psychiatrists/psychologist))
- Optimal local treatment with saline irrigation and topical nasal steroids for at least three months (unless contraindicated)
- Evidence of type 2 inflammation
- Need for systemic corticosteroids (at least two courses/year OR long-term treatment >3 months) or contraindication to systemic steroids
Key exclusion criteria (10 listed)
- Systemic corticosteroid treatment within the last three months
- Endoscopic sinus surgery (ESS) within the last six months
- Non-adherent to medicine regimens
- Hypersensitivity to the active substance or any of the excipients in the two IMPs
- Not able to understand spoken and/or written Danish
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 |
|---|---|---|
| dupilumabAlso: DupixentSubcutaneus injections in standard doses, i.e. 300 mg s.c. every 2 weeks. | Biological | Dupilumab week 0-24 300 mg/2 weeks, Dupilumab week 24-48 300 mg/2 weeks, Dupilumab week 24-48 300 mg/4 weeks |
| mepolizumabAlso: NucalaSubcutaneus injections in standard doses, i.e. 100 mg s.c. every 4 weeks. | Biological | Mepolizumab week 0-24 100 mg/4 weeks, Mepolizumab week 24-48 100 mg/4 weeks |
Primary outcome
SNOT-22
Time frame: Week 24
Sino-Nasal Outcome Test 22 - change in score since baseline is measured.
NPS
Time frame: Week 24
Nasal Polyp Score (0-8): 0 is no polyps, 4 is polyps extending below inferior turbinate's lower border. Each side is scored. The change in score at week 24 since baseline is measured.
9 secondary outcomes
SNOT-22
Time frame: Week 48
NPS
Time frame: Week 48
Smell score (Sniffin' Sticks Identification Test-16- SSIT-16)
Time frame: Week 48
Asthma control (Asthma Control Questionnaire)
Time frame: Week 48
Nasal Congestion Score (NCS)
Time frame: Week 48
Visual Analogue Scale of: smell/asthma/Chronic rhinosinusitis/N-ERD
Time frame: Week 48
Proportion meeting the evaluation criteria set by the DMC
Time frame: Week 48
Fraction of Nitrous Oxide in expired air (FeNO)
Time frame: Week 48
Proportion needing rescue treatment
Time frame: Week 48
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 1 Jul 2025.
- 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.
Christian Pedersen, MD principal investigator
Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
Christian von Buchwald study director
Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
9 sites 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 and mepolizumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma; Eosinophilic, run by Copenhagen University Hospital, Rigshospitalet at 9 sites in Denmark.
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 11 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. 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?
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?
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?
SNOT-22 (time frame: Week 24). The study lists 2 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 1 Jul 2025.