NCT06617754

International Severe CRSwNP Registry 2024-2028

InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Vibeke Backer · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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".

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: 1. Delphi process to point at the viable of importance. 2. The speed and size of SNOT-22 reduction 3. The speed and size of NPS reduction 4. The speed and size of Nasal congestion score (NCS) reduction 5. The speed and size of smell score increase. 6. The CTscan/Lund-Mackay score response 7. The evolution of the response on VAS scale (patients) 8. The Type 2 biomarkers at entrance and during the study 9. The (non)responder percentages defined based on EUFOREA criteria 10. The use of OCS (amount and frequency) 11. The frequency and time (days) since last sinus surgery 12. The effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and NSAID intolerance) in patients with CRSwNP 13. The reduced in need of Otrivin or similar drugs 14. Differences between inclusion criteria for biologic drugs, and differences between countries.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

Type	Name	Description
BIOLOGICAL	Biologic drugs	Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies

Timeline

• Start date: 2025-03-31
• Primary completion: 2030-01-01
• Completion: 2032-01-01
• First posted: 2024-09-27
• Last updated: 2025-04-08

Locations

1 site across 1 country: Denmark