Clinical trial NCT06617754: International Severe CRSwNP Registry 2024-2028
Official title: InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Keywords: CRSwNP
Asthma
Biologic treatment
Effect of treatment
Different geographic collection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The European Forum for Research and Education in Allergy and Airway Diseases
First posted: 2024-09-27
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
measure: Change in Nasal Polyp Score (NPS)
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
measure: Change in visual analogue scale (VAS)
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
measure: Change in olfactory function
timeFrame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Rhinolaryngology Head & Neck surgery and Audiology
Study officials:
References: