International Severe CRSwNP Registry 2024-2028 (INVENT)

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".

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
• Intervention / Treatment: Biological: Biologic drugs

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Department of Rhinolaryngology Head & Neck surgery and Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients from Danish registry of global airways; Patients included in the Danish Global Airways Registry	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Belgian registry of global airways; Patients included in the Belgian Global Airways Registry	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Netherlands registry of global airways; Patients included in the Netherlands registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the German registry of global airways; Patients included in the German registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Swiss registry of global airways; Patients included in the Swiss registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Italian registry of global airways; Patients included in the Italian registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Portuguese registry of global airways; Patients included in the Portuguese registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Finnish registry of global airways; Patients included in the Finnish registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the US registry of global airways; Patients included in the US registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from the Australian registry of global airways; Patients included in the Australian registry of global airways	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from Spanish registry of global airways; Patients included in the Spanish Global Airways Registry	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from Polish registry of global airways; Patients included in the Polish Global Airways Registry	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Patients from French registry of global airways; Patients included in the French Global Airways Registry	Biological: Biologic drugs; Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up

Collaborators and Investigators

• Sponsor: Vibeke Backer
• Collaborators: The European Forum for Research and Education in Allergy and Airway Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; CRSwNP; Biologic treatment; Effect of treatment; Different geographic collection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Sinusitis; Paranasal Sinus Diseases; Polyps; Rhinosinusitis; Nasal Polyps
• Other Study ID Numbers: H-21020685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No