Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617754
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
International Severe CRSwNP Registry 2024-2028
Sponsor:
None
Organization:
None
Study Overview
Official Title:
InternatioNal SeVerE CRSwNP Registry INVENT 2024-2028
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVENT
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 CTscanLund-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 nonresponder 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
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 CTscanLund-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 nonresponder 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None