2025-524495-39-00招募中4 期
Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 8
- 主要终点
- The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.
研究概览
简要总结
To compare Tezepelumab and Dupilumab with respect to a clinical meaningful improvement of nasal polyp disease as defined by a minimal reduction of nasal polyp score (NPS) by 1 point or a reduction in sino-nasal outcome test SNOT)-22 by 8.9 points between baseline and 12 months
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the study
- •Suffer from uncontrolled CRSwNP according to EPOS criteria
- •Indication for biologic treatment in the opinion of the investigator and according to the reimbursement criteria established by the Austrian Federation of Social Insurances: *History of surgical treatment for CRSwNP *Inadequate response to systemic corticosteroid treatment
排除标准
- •Pregnancy (as determined by beta human chorionic gonadotropin (β-HCG) test)
- •A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Patients receiving ongoing or having received biological therapy in the last 3 months for type-2 diseases like asthma, atopic dermatitis, chronic obstructive pulmonary disease (COPD), urticaria and eosinophilic esophagitis
- •Patients who intend to achieve pregnancy within the study period
- •Systemic corticosteroid treatment within the last three months
- •Hypersensitivity to the active substance or any of the excipients in the two IMPs
- •Participation in another investigational drug trial antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis
- •Breastfeeding patients
- •Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
- •Patients with permanent immunosuppression
研究组 & 干预措施
Dupixent 200 mg solution for injection in pre-filled pen
Test
干预措施: Dupixent 200 mg solution for injection in pre-filled pen (Drug)
Tezspire 210 mg solution for injection in pre-filled syringe
Test
干预措施: Tezspire 210 mg solution for injection in pre-filled syringe (Drug)
结局指标
主要结局
The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.
The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.
次要结局
- Percentage of patients with good-excellent (4-5 criteria), poor-moderate (1-3 criteria) and no response (0 criteria) according to EPOS/EUROFREA criteria during one year of therapy with Dupilumab or Tezepelumab
- Change in in QoL parameters (e.g., SNOT-22 score and subcategories, scale 0-110, EQ-5D-3L, scale: 5-15) and clinical parameters (e.g. NPS, scale: 0-8; ECP, 0-200µg/L) during one year of therapy with Dupilumab or Tezepelumab
- Change in objective (Sniffin’sticks, 0-16 points) and subjective (VAS for olfactory performance (0-10cm), SNOT 22 items) during one year of therapy with Dupilumab or Tezepelumab
- change in peak nasal inspiratory flow (PNIF, 0-370 L/min) or FEV 1 (spirometer, 0-ca.120%(young patients)) during one year of therapy with Dupilumab or Tezepelumab
- change in perception of asthma control (ACT 0-25 Points or AQLQ 0-105 points) during one year of therapy with Dupilumab or Tezepelumab
- change in perception of CRS symptoms (VAS, 0-10 cm) during one year of therapy with Dupilumab or Tezepelumab
- occurrence of side effect as determined by diary or patients oral report during one year of therapy with Dupilumab or Tezepelumab, change in routine blood parameters
- Change in allergic symptoms (TRSS 0-21 points, questionnaire) and allergic sensitization (skin prick test, number of sensitizations) during one year of treatment with Dupilumab or Tezepelumab
- Change in diversity (Chao1 and Shannon Index, 0-open) and abundance (0-open) of the nasal microbiome during one year of treatment with Dupilumab or Tezepelumab
- Change in relative levels of mediators (Normalized Protein Expression=NPX, 0-open) as determined by OLINK during one year of treatment with Dupilumab or Tezepelumab
- Change in relative gene expression (Δ Cycle threshold (Ct): Difference between Ct of the target gene and a reference gene, 0-open) of oxidative stress response induced genes during one year of treatment with Dupilumab or Tezepelumab
- Change in allergic sensitization (allergen-specific IgE levels, kUA/L) in nasal secretions and serum during one year of treatment with Dupilumab or Tezepelumab
研究者
Department of Ear, Nose and Throat Disease
Scientific
Medical University Of Vienna
研究点 (8)
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