International Severe CRSwNP Registry 2024-2028 (INVENT)

Vibeke Backer

Status: Active, not recruiting

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Treatments: Biological: Biologic drugs

Study type: Observational

Funder types: Other

Identifiers

NCT06617754

H-21020685

Details and patient eligibility

About

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".

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of CRSwNP
• Indication for biologic treatment as suggested by EPOS/EUFOREA
• Have been followed for 6 months

Exclusion criteria

• Unilateral polyps
• Non-Type-2 inflammation
• Treatment less than 6 months

Trial design

3,000 participants in 13 patient groups

Patients from Danish registry of global airways

Description:

Patients included in the Danish Global Airways Registry

Treatment:

Biological: Biologic drugs

Patients from the Belgian registry of global airways

Description:

Patients included in the Belgian Global Airways Registry

Treatment:

Biological: Biologic drugs

Patients from the Netherlands registry of global airways

Description:

Patients included in the Netherlands registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the German registry of global airways

Description:

Patients included in the German registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the Swiss registry of global airways

Description:

Patients included in the Swiss registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the Italian registry of global airways

Description:

Patients included in the Italian registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the Portuguese registry of global airways

Description:

Patients included in the Portuguese registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the Finnish registry of global airways

Description:

Patients included in the Finnish registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the US registry of global airways

Description:

Patients included in the US registry of global airways

Treatment:

Biological: Biologic drugs

Patients from the Australian registry of global airways

Description:

Patients included in the Australian registry of global airways

Treatment:

Biological: Biologic drugs

Patients from Spanish registry of global airways

Description:

Patients included in the Spanish Global Airways Registry

Patients from Polish registry of global airways

Description:

Patients included in the Polish Global Airways Registry

Treatment:

Biological: Biologic drugs

Patients from French registry of global airways

Description:

Patients included in the French Global Airways Registry

Treatment:

Biological: Biologic drugs