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| Name | Class |
|---|---|
| The European Forum for Research and Education in Allergy and Airway Diseases | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients from Danish registry of global airways | Patients included in the Danish Global Airways Registry |
| |
| Patients from the Belgian registry of global airways | Patients included in the Belgian Global Airways Registry |
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| Patients from the Netherlands registry of global airways | Patients included in the Netherlands registry of global airways |
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| Patients from the German registry of global airways | Patients included in the German registry of global airways |
| |
| Patients from the Swiss registry of global airways | Patients included in the Swiss registry of global airways |
| |
| Patients from the Italian registry of global airways | Patients included in the Italian registry of global airways |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic drugs | Biological | Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rhinolaryngology Head & Neck surgery and Audiology | Copenhagen | Denmark | DK-2100 | Denmark |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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| Patients from the Portuguese registry of global airways | Patients included in the Portuguese registry of global airways |
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| Patients from the Finnish registry of global airways | Patients included in the Finnish registry of global airways |
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| Patients from the US registry of global airways | Patients included in the US registry of global airways |
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| Patients from the Australian registry of global airways | Patients included in the Australian registry of global airways |
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| Patients from Spanish registry of global airways | Patients included in the Spanish Global Airways Registry |
| Patients from Polish registry of global airways | Patients included in the Polish Global Airways Registry |
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| Patients from French registry of global airways | Patients included in the French Global Airways Registry |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |