Chronic Rhinosinusitis With Nasal PolypsDUPIREALNCT05529784
Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 19 sites in Italy.
Trial summary
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 19 sitesItaly
- Study dates
- 6 Oct 2021to 1 Oct 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: We included all the patients that were referred to Dupilumab therapy, prescribed accordingly to the plan provided by Italian Agency of Drugs.
Who may be able to join
- confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy;
- severe disease stage defined by NPS ≥5 or SNOT-22 ≥50;
- inadequate symptom control with INCS therapy;
- failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit
Who cannot join
- pregnant women;
- immunosuppressive therapy;
- patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy;
- concomitant long-term corticosteroid therapy for chronic autoimmune disorders
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
AUSL Bologna
Bologna
Azienda Ospedaliero-Universitaria Policlinico S. Marco
Catania
AUSL Latina
Latina
ASST Santi Paolo e Carlo - Presidio San Paolo
Milan
IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
IRCCS San Raffaele
Milan
Azienda Ospedaliero-Universitaria di Modena
Modena
A.O.R.N. Ospedali dei Colli
Naples
Azienda Ospedaliera Policlinico Federico II
Naples
Ospedale maggiore di Novara
Novara
Ospedale S.Luigi Gonzaga, Università di Torino
Orbassano
Azienda Ospedaliero-Universitaria di Padova
Padova
Policlinico San Matteo-Università di Pavia
Pavia
Azienda Ospedaliero-Universitaria Pisana
Pisa
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia
ASL Roma 5
Roma
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma
Università La Sapienza
Roma
Azienda Ospedaliero-Universitaria di Sassari
Sassari
About this study
Official title: Effectiveness of Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling.
So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.
Read more
Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting.
The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS).
The secondary objectives are:
- the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction
- the assessment of the patients' quality of life
- the recording of major and minor complications
- the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021
- the assessment of efficacy based on concomitant disease (Asthma and ASA triad)
- the evaluation of potential predictors of clinical response to the therapy
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- 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 300mg in pre-filled injector Q2W
| Study group | Role | What they receive |
|---|---|---|
| Severe, uncontrolled CRSwNP patients in therapy with Dupilumab | Not described 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.
Nasal Polyp Score (NPS)
Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
Measured: 12 months
Secondary outcomes (13)
Nasal Polyp Score (NPS)
Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
Measured: 24 months
Nasal congestion score (NCS)
Nasal congestion. Range 0-3. Higher score describes a worse condition
Measured: 12 months and 24 months
Sinonasal outcome test (SNOT-22)
Symptoms. Range 0-110. Higher score describes a worse condition
Measured: 12 months and 24 months
Sniffin' sticks identification test
Olfaction. Range 0-16. Higher score describes a better condition
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for nasal congestion
Nasal congestion. Range 0-10. Higher score describes a more severe symptom
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for olfaction loss
Olfaction loss. Range 0-10. Higher score describes a more severe symptom
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for craniofacial pain
Craniofacial pain. Range 0-10. Higher score describes a more severe symptom
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for sleeping disorders
Sleeping disorders. Range 0-10. Higher score describes a more severe symptom
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for rhinorrhea
Rhinorrhea. Range 0-10. Higher score describes a more severe symptom
Measured: 12 months and 24 months
Visual Analog Scale (VAS) for quality of life
Quality of life. Range 0-10. Higher score describes a worse quality of life
Measured: 12 months and 24 months
Need for surgery
Number of surgeries performed during therapy
Measured: 12 months and 24 months
Intranasal corticosteroid adherence
Number of days of suspension of intranasal corticosteroids
Measured: 12 months and 24 months
Need for rescue oral corticosteroids
Number of short cycles of oral corticosteroids during therapy
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start6 Oct 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2023 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DE CORSO EUGENIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Eugenio De Corso, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529784
- Sponsor's protocol ID
- 0034704/21
- Acronym
- DUPIREAL
- Status last verified
- Feb 2023
- First submitted
- 2 Sep 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
- ClinicalTrials.gov ID
- NCT05529784
- Acronym / sponsor ID
- DUPIREAL / 0034704/21
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 7 Sep 2022 (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.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling.
So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.
Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting.
The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS).
The secondary objectives are:
- the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction
- the assessment of the patients' quality of life
- the recording of major and minor complications
- the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021
- the assessment of efficacy based on concomitant disease (Asthma and ASA triad)
- the evaluation of potential predictors of clinical response to the therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe, uncontrolled CRSwNP patients in therapy with Dupilumab | – | Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We included all the patients that were referred to Dupilumab therapy, prescribed accordingly to the plan provided by Italian Agency of Drugs.
Key inclusion criteria (4 listed)
- confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy;
- severe disease stage defined by NPS ≥5 or SNOT-22 ≥50;
- inadequate symptom control with INCS therapy;
- failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit
Key exclusion criteria (4 listed)
- pregnant women;
- immunosuppressive therapy;
- patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy;
- concomitant long-term corticosteroid therapy for chronic autoimmune disorders
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 300mg in pre-filled injector Q2W | Drug | Severe, uncontrolled CRSwNP patients in therapy with Dupilumab |
Primary outcome
Nasal Polyp Score (NPS)
Time frame: 12 months
Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
13 secondary outcomes
Nasal Polyp Score (NPS)
Time frame: 24 months
Nasal congestion score (NCS)
Time frame: 12 months and 24 months
Sinonasal outcome test (SNOT-22)
Time frame: 12 months and 24 months
Sniffin' sticks identification test
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for nasal congestion
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for olfaction loss
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for craniofacial pain
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for sleeping disorders
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for rhinorrhea
Time frame: 12 months and 24 months
Visual Analog Scale (VAS) for quality of life
Time frame: 12 months and 24 months
Need for surgery
Time frame: 12 months and 24 months
Intranasal corticosteroid adherence
Time frame: 12 months and 24 months
Need for rescue oral corticosteroids
Time frame: 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Eugenio De Corso, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
19 sites 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 With Nasal Polyps, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 19 sites in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. 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?
Results are not available in the source record.
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?
Nasal Polyp Score (NPS) (time frame: 12 months). 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 21 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.