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临床试验/NCT06617754
NCT06617754进行中(未招募)不适用

InternatioNal seVerE CRSwNP Registry (INVENT) 2024-2028

Vibeke Backer1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年3月31日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,000
试验地点
1
主要终点
Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score

研究概览

简要总结

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".

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Symptoms of CRSwNP
  • Indication for biologic treatment as suggested by EPOS/EUFOREA
  • Have been followed for 6 months

排除标准

  • Unilateral polyps
  • Non-Type-2 inflammation
  • Treatment less than 6 months

研究组 & 干预措施

Patients from Danish registry of global airways

Patients included in the Danish Global Airways Registry

干预措施: Biologic drugs (Biological)

Patients from the Belgian registry of global airways

Patients included in the Belgian Global Airways Registry

干预措施: Biologic drugs (Biological)

Patients from the Netherlands registry of global airways

Patients included in the Netherlands registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the German registry of global airways

Patients included in the German registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the Swiss registry of global airways

Patients included in the Swiss registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the Italian registry of global airways

Patients included in the Italian registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the Portuguese registry of global airways

Patients included in the Portuguese registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the Finnish registry of global airways

Patients included in the Finnish registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the US registry of global airways

Patients included in the US registry of global airways

干预措施: Biologic drugs (Biological)

Patients from the Australian registry of global airways

Patients included in the Australian registry of global airways

干预措施: Biologic drugs (Biological)

Patients from Polish registry of global airways

Patients included in the Polish Global Airways Registry

干预措施: Biologic drugs (Biological)

Patients from French registry of global airways

Patients included in the French Global Airways Registry

干预措施: Biologic drugs (Biological)

结局指标

主要结局

Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Vibeke Backer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vibeke Backer

MD, DMSci, Professor

Rigshospitalet, Denmark

研究点 (1)

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