Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
3000 participants
OBSERVATIONAL
2025-03-31
2032-01-31
Brief Summary
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Detailed Description
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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".
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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients from Danish registry of global airways
Patients included in the Danish Global Airways Registry
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
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
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
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
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
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
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
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
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
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
No interventions assigned to this group
Patients from Polish registry of global airways
Patients included in the Polish Global Airways Registry
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
Biologic drugs
Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Interventions
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Biologic drugs
Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Eligibility Criteria
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Inclusion Criteria
* Indication for biologic treatment as suggested by EPOS/EUFOREA
* Have been followed for 6 months
Exclusion Criteria
* Non-Type-2 inflammation
* Treatment less than 6 months
ALL
No
Sponsors
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The European Forum for Research and Education in Allergy and Airway Diseases
OTHER
Vibeke Backer
OTHER
Responsible Party
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Vibeke Backer
MD, DMSci, Professor
Locations
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Department of Rhinolaryngology Head & Neck surgery and Audiology
Copenhagen, Denmark, Denmark
Countries
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Other Identifiers
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H-21020685
Identifier Type: -
Identifier Source: org_study_id
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