Chronic Rhinosinusitis With Nasal PolypsBIOPOSENCT05228041
BIOlogics in Severe Nasal POlyposis SurvEy
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by University Hospital, Lille at 1 site in France.
Trial summary
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. 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?
- Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
Who may be able to join
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
Who cannot join
- Oral corticotherapy in the previous month;
- Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months apart from ongoing biotherapies for severe asthma;
- Hypersensitivity to humanized antibodies ;
- Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
- Pregnant or breast-feeding women;
- Patient without social coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
Read more
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
Read the detailed description
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
- Keywords
- Biologic, nasal polyp, chronic rhinosinusitis, eosinophil, endotype
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)Drug
Also called dupilumab, mepolizumab, omalizumab, tezepelumab
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks)
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6
from 0 to 110 , 110 = worst outcome
Measured: Day0, Month 6
Secondary outcomes (9)
SNOT 22 (Sinonasal Outcome Test-22) scores
from 0 to 110 , 110 = worst outcome
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for nasal obstruction
from 0 to 10, 10 = worst outcome
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for smell lost
from 0 to 10, 10 = worst outcome
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for rhinorrhea
from 0 to 10, 10 = worst outcome
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for craniofacial pain
from 0 to 10, 10 = worst outcome
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Number of systemic corticosteroid treatment courses between each visit
number of treatment sequencies
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Delay to first surgical procedure
time between biologic onset and need for surgery
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood eosinophil count
number of cells per mm3
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood total IgE concentrations
concentration expressed by KUI/L
Measured: Day 0, Month 3, Month 6, Month 12 and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Feb 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Mortuaire, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228041
- Sponsor's protocol ID
- DRI_2021/0030
- Acronym
- BIOPOSE
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Favier V, Daveau C, Carsuzaa F, Fieux M, Vandersteen C, Castillo L, Papon JF, de Gabory L, Saroul N, Verillaud B, Rumeau C, Jankowski R, Michel J, de Bonnecaze G, Lecanu JB, Coste A, Bequignon E, Malard O, Mortuaire G. Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey. BMJ Open. 2024 May 15;14(5):e083112. doi: 10.1136/bmjopen-2023-083112.
PubMed 38749694
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT05228041
- Acronym / sponsor ID
- BIOPOSE / DRI_2021/0030
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- Biologic, nasal polyp, chronic rhinosinusitis, eosinophil, endotype
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Feb 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.
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
Detailed description
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
Key inclusion criteria (1 listed)
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
Key exclusion criteria (6 listed)
- Oral corticotherapy in the previous month;
- Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months apart from ongoing biotherapies for severe asthma;
- Hypersensitivity to humanized antibodies ;
- Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
- Pregnant or breast-feeding women;
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 |
|---|---|---|
| Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)Also: dupilumab, mepolizumab, omalizumab, tezepelumabDrug prescription according to their marketing approval (subcutaneously, every month or every two weeks) | Drug | – |
Primary outcome
6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6
Time frame: Day0, Month 6
from 0 to 110 , 110 = worst outcome
9 secondary outcomes
SNOT 22 (Sinonasal Outcome Test-22) scores
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for nasal obstruction
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for smell lost
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for rhinorrhea
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for craniofacial pain
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Number of systemic corticosteroid treatment courses between each visit
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Delay to first surgical procedure
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood eosinophil count
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood total IgE concentrations
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
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 29 Apr 2026.
- Results publication: PubMed 38749694Favier V, Daveau C, Carsuzaa F, Fieux M, Vandersteen C, Castillo L, Papon JF, de Gabory L, Saroul N, Verillaud B, Rumeau C, Jankowski R, Michel J, de Bonnecaze G, Lecanu JB, Coste A, Bequignon E, Malard O, Mortuaire G. Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey. BMJ Open. 2024 May 15;14(5):e083112. doi: 10.1136/bmjopen-2023-083112.
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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.
Geoffrey Mortuaire, MD principal investigator
University Hospital, Lille
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 With Nasal Polyps, run by University Hospital, Lille at 1 site in France.
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 1 inclusion and 6 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 29 Apr 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 France. 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?
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?
6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6 (time frame: Day0, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228041, which also lists 1 linked publication.
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 29 Apr 2026.