Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)INVENTNCT06617754
International Severe CRSwNP Registry 2024-2028
An observational study of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Vibeke Backer at 1 site in Denmark.
Trial summary
The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- Biologic drugs
- How many people
- 3,000 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Mar 2025to Jan 2032
- How long will I take part?
- 60 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In Denmark, the study population consists of patients suffering CRSwNP and treated with biologic treatments included in global airways Danish/National registry. In the other countries, the study population consists of patients suffering CRSwNP and treated with biologic treatments who are included in local Registries.
Who may be able to join
- Symptoms of CRSwNP
- Indication for biologic treatment as suggested by EPOS/EUFOREA
- Have been followed for 6 months
Who cannot join
- Unilateral polyps
- Non-Type-2 inflammation
- Treatment less than 6 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rhinolaryngology Head & Neck surgery and Audiology
Copenhagen, Denmark, DK-2100
About this study
Official title: InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028
The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".
Read the detailed description
Regional or national registries have evaluated the efficacy of different biologics in severe uncontrolled CRSwNP coordinated by several academic centres in Europe. At present, these registries have not been merged nor allowed the comparison in real-life efficacy between the 3 different monoclonal antibodies (mepolizumab, dupilumab, omalizumab) with different mechanism which has been approved for the indication of CRSwNP and the effect of the nasal polyp score. Some countries have allowance for some of the different biologic drugs, other countries have other combination of the drugs. Despite the heterogeneity in availability of biologics for the indication of CRSwNP, the merge of data might lead to very interesting outcomes.
The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".
Compare the outcomes of different biologics in different national registries, at screening and 6-month follow-up: Primary aims:
- Delphi process to point at the viable of importance.
- The speed and size of SNOT-22 reduction
- The speed and size of NPS reduction
- The speed and size of Nasal congestion score (NCS) reduction
- The speed and size of smell score increase.
- The CTscan/Lund-Mackay score response
- The evolution of the response on VAS scale (patients)
- The Type 2 biomarkers at entrance and during the study
- The (non)responder percentages defined based on EUFOREA criteria
- The use of OCS (amount and frequency)
- The frequency and time (days) since last sinus surgery
- The effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and NSAID intolerance) in patients with CRSwNP
- The reduced in need of Otrivin or similar drugs
- Differences between inclusion criteria for biologic drugs, and differences between countries.
- Being tested
- Biologic drugs
- Keywords
- CRSwNP, Asthma, Biologic treatment, Effect of treatment, Different geographic collection
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic drugsBiological
Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
| Study group | Role | What they receive |
|---|---|---|
| Patients from Danish registry of global airways | Patients included in the Danish Global Airways Registry Receives: Biological: Biologic drugs | |
| Patients from the Belgian registry of global airways | Patients included in the Belgian Global Airways Registry Receives: Biological: Biologic drugs | |
| Patients from the Netherlands registry of global airways | Patients included in the Netherlands registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the German registry of global airways | Patients included in the German registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the Swiss registry of global airways | Patients included in the Swiss registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the Italian registry of global airways | Patients included in the Italian registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the Portuguese registry of global airways | Patients included in the Portuguese registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the Finnish registry of global airways | Patients included in the Finnish registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the US registry of global airways | Patients included in the US registry of global airways Receives: Biological: Biologic drugs | |
| Patients from the Australian registry of global airways | Patients included in the Australian registry of global airways Receives: Biological: Biologic drugs | |
| Patients from Spanish registry of global airways | Patients included in the Spanish Global Airways Registry | |
| Patients from Polish registry of global airways | Patients included in the Polish Global Airways Registry Receives: Biological: Biologic drugs | |
| Patients from French registry of global airways | Patients included in the French Global Airways Registry Receives: Biological: Biologic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score
The success rate indicated by a significant change in health-related quality of life related to nasal symptoms measured with the questionnaire SNOT22.
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Change in Nasal Polyp Score (NPS)
The NPS scale ranges from 0 (no polyp) to 4 (large polyps) for each nostril. The total score ranging from 0-8.
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Change in visual analogue scale (VAS)
Change in VAS related to nasal symptoms. Minimum score = 0 and maximum score = 10. High score indicates worse nasal symptoms
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Change in olfactory function
Change in olfactory function measured with Sniffin' Stick 16 blue. Minimum score = 0. Maximum score = 16. A score between 0-8 indicates anosmia, a score between 8-11 indicates hyposmia, and a score >11 indicates normosmia.
Measured: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start31 Mar 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2032 (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 Polyps (CRSwNP)Studies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Vibeke Backer
- Sponsor type
- University, hospital or other
- Collaborators
- The European Forum for Research and Education in Allergy and Airway Diseases
- Responsible party
- Sponsor-investigator, Vibeke Backer, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617754
- Sponsor's protocol ID
- H-21020685
- Acronym
- INVENT
- Status last verified
- Apr 2025
- First submitted
- 26 Sep 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028
- ClinicalTrials.gov ID
- NCT06617754
- Acronym / sponsor ID
- INVENT / H-21020685
- Keywords
- CRSwNP, Asthma, Biologic treatment, Effect of treatment, Different geographic collection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Vibeke BackerUniversity, hospital or other
- Collaborators
- The European Forum for Research and Education in Allergy and Airway Diseases
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 27 Sep 2024 (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 objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".
Detailed description
Regional or national registries have evaluated the efficacy of different biologics in severe uncontrolled CRSwNP coordinated by several academic centres in Europe. At present, these registries have not been merged nor allowed the comparison in real-life efficacy between the 3 different monoclonal antibodies (mepolizumab, dupilumab, omalizumab) with different mechanism which has been approved for the indication of CRSwNP and the effect of the nasal polyp score. Some countries have allowance for some of the different biologic drugs, other countries have other combination of the drugs. Despite the heterogeneity in availability of biologics for the indication of CRSwNP, the merge of data might lead to very interesting outcomes.
The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".
Compare the outcomes of different biologics in different national registries, at screening and 6-month follow-up: Primary aims:
- Delphi process to point at the viable of importance.
- The speed and size of SNOT-22 reduction
- The speed and size of NPS reduction
- The speed and size of Nasal congestion score (NCS) reduction
- The speed and size of smell score increase.
- The CTscan/Lund-Mackay score response
- The evolution of the response on VAS scale (patients)
- The Type 2 biomarkers at entrance and during the study
- The (non)responder percentages defined based on EUFOREA criteria
- The use of OCS (amount and frequency)
- The frequency and time (days) since last sinus surgery
- The effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and NSAID intolerance) in patients with CRSwNP
- The reduced in need of Otrivin or similar drugs
- Differences between inclusion criteria for biologic drugs, and differences between countries.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 60 Months
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Patients from Danish registry of global airways | – | Biological: Biologic drugsPatients included in the Danish Global Airways Registry |
| Patients from the Belgian registry of global airways | – | Biological: Biologic drugsPatients included in the Belgian Global Airways Registry |
| Patients from the Netherlands registry of global airways | – | Biological: Biologic drugsPatients included in the Netherlands registry of global airways |
| Patients from the German registry of global airways | – | Biological: Biologic drugsPatients included in the German registry of global airways |
| Patients from the Swiss registry of global airways | – | Biological: Biologic drugsPatients included in the Swiss registry of global airways |
| Patients from the Italian registry of global airways | – | Biological: Biologic drugsPatients included in the Italian registry of global airways |
| Patients from the Portuguese registry of global airways | – | Biological: Biologic drugsPatients included in the Portuguese registry of global airways |
| Patients from the Finnish registry of global airways | – | Biological: Biologic drugsPatients included in the Finnish registry of global airways |
| Patients from the US registry of global airways | – | Biological: Biologic drugsPatients included in the US registry of global airways |
| Patients from the Australian registry of global airways | – | Biological: Biologic drugsPatients included in the Australian registry of global airways |
| Patients from Spanish registry of global airways | – | –Patients included in the Spanish Global Airways Registry |
| Patients from Polish registry of global airways | – | Biological: Biologic drugsPatients included in the Polish Global Airways Registry |
| Patients from French registry of global airways | – | Biological: Biologic drugsPatients included in the French Global Airways Registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In Denmark, the study population consists of patients suffering CRSwNP and treated with biologic treatments included in global airways Danish/National registry. In the other countries, the study population consists of patients suffering CRSwNP and treated with biologic treatments who are included in local Registries.
Key inclusion criteria (3 listed)
- Symptoms of CRSwNP
- Indication for biologic treatment as suggested by EPOS/EUFOREA
- Have been followed for 6 months
Key exclusion criteria (3 listed)
- Unilateral polyps
- Non-Type-2 inflammation
- Treatment less than 6 months
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 drugsBiologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies | Biological | Patients from Danish registry of global airways, Patients from French registry of global airways, Patients from Polish registry of global airways, Patients from the Australian registry of global airways, Patients from the Belgian registry of global airways, Patients from the Finnish registry of global airways, Patients from the German registry of global airways, Patients from the Italian registry of global airways, Patients from the Netherlands registry of global airways, Patients from the Portuguese registry of global airways, Patients from the Swiss registry of global airways, Patients from the US registry of global airways |
Primary outcome
Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
The success rate indicated by a significant change in health-related quality of life related to nasal symptoms measured with the questionnaire SNOT22.
Change in Nasal Polyp Score (NPS)
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
The NPS scale ranges from 0 (no polyp) to 4 (large polyps) for each nostril. The total score ranging from 0-8.
Change in visual analogue scale (VAS)
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Change in VAS related to nasal symptoms. Minimum score = 0 and maximum score = 10. High score indicates worse nasal symptoms
Change in olfactory function
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Change in olfactory function measured with Sniffin' Stick 16 blue. Minimum score = 0. Maximum score = 16. A score between 0-8 indicates anosmia, a score between 8-11 indicates hyposmia, and a score >11 indicates normosmia.
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 8 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (CRSwNP), run by Vibeke Backer at 1 site 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 3 inclusion and 3 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 8 Apr 2025. 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 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.
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?
Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score (time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up). The study lists 4 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 8 Apr 2025.