Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Conditions
Keywords
CRSwNP, Asthma, Biologic treatment, Effect of treatment, Different geographic collection
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.
Interventions
BIOLOGICALBiologic drugs
Biologic drugs including Mepolizumab, Dupilumab, Omalizumab, Tezepelumab, or future monoclonal antibodies
Sponsors
The European Forum for Research and Education in Allergy and Airway Diseases
Vibeke Backer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score | 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up | The success rate indicated by a significant change in health-related quality of life related to nasal symptoms measured with the questionnaire SNOT22. |
| Change in Nasal Polyp Score (NPS) | 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up | The NPS scale ranges from 0 (no polyp) to 4 (large polyps) for each nostril. The total score ranging from 0-8. |
| Change in visual analogue scale (VAS) | 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up | Change in VAS related to nasal symptoms. Minimum score = 0 and maximum score = 10. High score indicates worse nasal symptoms |
| Change in olfactory function | 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months follow up | 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. |
Countries
Denmark
Outcome results
None listed