An observational study in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), sponsored by Vibeke Backer. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Vibeke Backer · Observational
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".
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:
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 100 across 81 observational studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Vibeke Backer is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients included in the Danish Global Airways Registry
Biological: Biologic drugs
Patients included in the Belgian Global Airways Registry
Biological: Biologic drugs
Patients included in the Netherlands registry of global airways
Biological: Biologic drugs
Patients included in the German registry of global airways
Biological: Biologic drugs
Patients included in the Swiss registry of global airways
Biological: Biologic drugs
Patients included in the Italian registry of global airways
Biological: Biologic drugs
Patients included in the Portuguese registry of global airways
Biological: Biologic drugs
Patients included in the Finnish registry of global airways
Biological: Biologic drugs
Patients included in the US registry of global airways
Biological: Biologic drugs
Patients included in the Australian registry of global airways
Biological: Biologic drugs
Patients included in the Spanish Global Airways Registry
Patients included in the Polish Global Airways Registry
Biological: Biologic drugs
Patients included in the French Global Airways Registry
Biological: Biologic drugs
Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Vibeke Backer