IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 315
- 试验地点
- 29
- 主要终点
- COMORBIDITIES AND RELEVANT MEDICAL HISTORY
研究概览
简要总结
This observational study aims to collect data in clinical practice on the clinical profile of patients treated with Tezepelumab from Q1 2024 to Q1 2025 according to the approved and reimbursed indication in Italy
详细描述
There is a current need to gain information on the clinical profile of patients eligible for treatment with Tezepelumab according to the approved and reimbursed indication in Italy. Moreover, being Tezepelumab the latest approved biologic drug for severe asthma, it is important to better understand clinical response to treatment in patients with high severe asthma burden as: patients with allergic-eosinophilic phenotype; patients with low eosinophils level; patients affected by severe asthma associated with sinonasal disease; biologic-naïve patients, as well as bio-treated patients. The present observational study aims at filling the above-mentioned knowledge gaps in the study population in terms of clinical course, disease control and clinical remission, use of healthcare resources (treatments, visits, hospitalizations), lung functions, biomarkers, and sinonasal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab);
- •Patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ERS-ATS or GINA guidelines) requiring a stable treatment of high doses of ICS and a long acting β2 agonist ± additional asthma controller;
- •Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications;
- •Patients who signed the ICF and privacy form.
- •Patients with continuous enrolment in the data source for at least 12-months before the index date.
- •Patients with at least three months of continuous enrolment in the data source after the index date.
排除标准
- •Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
- •Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date.
- •Patients who, during the observation period, participated in studies imposing a specific patient's management strategy, which does not correspond to the site's normal clinical practice.
研究组 & 干预措施
Severe uncontrolled asthma patients
Adolescent and adult patients with severe uncontrolled asthma treated with tezepelumab will be enrolled in the study. Patients can be enrolled if they received at least one dose of tezepelumab either within the sampling program or as per routine clinical practice between February 2024 and March 2025.
干预措施: Tezepelumab (Biological)
结局指标
主要结局
COMORBIDITIES AND RELEVANT MEDICAL HISTORY
时间窗: Basal
To describe the respiratory and non-respiratory related conditions in patients with severe asthma who initiated treatment with tezepelumab
Demographic and Clinic characterization
时间窗: Basal
To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab
次要结局
- Exacerbation rate(Basal, 12 months, 24 months)
- mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use(Basal, 12 months, 24 months)
- ACT (Asthma Control Test) score(Basal, 12 months, 24 months)
- Asthma Control Questionnaire (ACQ) score(Basal, 12 months, 24 months)
- Lung function FEV1 (L)(Basal, 12 months, 24 months)
- Lung function FVC (L)(Basal, 12 months, 24 months)
- Lung function % predicted FVC(Basal, 12 months, 24 months)
- Lung function % predicted FEV1(Basal, 12 months, 24 months)
- Biomarkers - BEC (blood eosinophils count)(Basal, 12 months, 24 months)
- Biomarkers - FeNO (Fractional exhaled Nitric Oxide)(Basal, 12 months, 24 months)
- Biomarkers - IgE (Immunoglobulin E)(Basal, 12 months, 24 months)
- Treatments(Basal, 12 months, 24 months)
- Clinical Remission(12 months, 24 months)