Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 420
- 试验地点
- 12
- 主要终点
- Socio-demographic variables: Age (years), Gender (male, female, other); Smoking status (Current smoker, Ex- smoker, Non-smoker) and cumulative index (packs/year); Height (cm) and weight (kg); Body Mass Index (BMI) (kg/m 2 )
研究概览
简要总结
Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain
详细描述
T-ROSS-II has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in Spain after its launch.
This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.
Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 105 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received at least 1 tezepelumab dose after commercialization in Spain diagnosed with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and a long-acting β2-agonist ± additional medications for asthma control.
- •Patients aged ≥12 years at the index date.
- •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 who received tezepelumab or 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 had initiated 3 or more non-tezepelumab biologic treatment (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) for severe asthma at any time prior to the index date).
结局指标
主要结局
Socio-demographic variables: Age (years), Gender (male, female, other); Smoking status (Current smoker, Ex- smoker, Non-smoker) and cumulative index (packs/year); Height (cm) and weight (kg); Body Mass Index (BMI) (kg/m 2 )
时间窗: Index date (treatment initiation with tezepelumab)
To describe the demographic characteristics of patients
Exacerbation (number of exacerbations)
时间窗: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
Comorbidities (e.g., allergic rhinitis, nasal polyposis, gastroesophageal reflux, chronic obstructive pulmonary disease (COPD), atopic dermatitis and other eosinophilic conditions, conditions related to OCS chronic use, etc.)
时间窗: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)
Number of respiratory infections and diseases in the previous 12 months and index date
时间窗: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)
Number of participants with an Allergy test (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)
时间窗: Only on the baseline (12 months prior to Index date)
次要结局
- FeNO (ppb)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- IgE (IU/mL)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Asthma Impairment and Risk Questionnaire (AIRQ)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Asthma Quality of Life Questionnaire (AQLQ)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Asthma Control Test (ACT)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Lung function measurements(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Blood neutrophil count (109 /L, mm^3)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- MiniAQLQ (Mini Asthma Quality of Life Questionnaire)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- SNOT-22 (Sino-Nasal Outcome Test)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))
- Blood eosinophil count (BEC) (109 /L, mm^3)(From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date))