Observational Retrospective Study To Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab in the Framework Of Use in Special Situations Prior to Commercialisation in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Exacerbations in the previous 12 months and Exacerbations from index date until all available follow-up (number and dates for each exacerbation episode)
研究概览
简要总结
The aim of this study is to provide the first results on the use of tezepelumab under clinical practice conditions in severe asthma patients who participated in the "foreign medication supply" program in Spain.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 12 years and older with severe asthma who were inadequately controlled with high dose inhaled corticosteroids plus another medicinal product
- •Received at least one dose of tezepelumab under the FMS program, established according to Royal Decree 1015 / 2009 (prior to commercialization)
排除标准
- •Subjects having received tezepelumab or any other biologic for the treatment of asthma in the context of a clinical trial at any time during the 12 months prior to the index date.
结局指标
主要结局
Exacerbations in the previous 12 months and Exacerbations from index date until all available follow-up (number and dates for each exacerbation episode)
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: 12 months before index date and index date (date of treatment initiation with tezepelumab)
When available, lung function measurements including spirometry, Inspiratory Capacity, and bronchodilator reversibility test.
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)
Lung function measurements including spirometry (FEV1(L), FVC(L), PEF(L/s), FEF25-75%(L/s), Inspiratory Capacity (IC) (L)), and bronchodilator reversibility test. From the spirometry measurements, the following will be calculated: FEV1/FVC ratio (%) and FEV1 % predicted (%)
FeNO (ppb)
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)
Allergy status (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)
Number of respiratory infections and diseases in the previous 12 months and index date
时间窗: In the previous 12 months and index date (date of treatment initiation with tezepelumab)
Blood Eosinophil count (109 /L, mm3 )
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)
IgE (IU/mL; kU/mL; ng/mL (mg/L); ng/dL (ng/100mL); ng%)
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)
Neutrophil count (10 9 /L, mm3 )
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)
Sputum biomarkers: sputum eosinophils (%); sputum neutrophils (%)
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)
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: Only on the index date (If no information referred to index date is available, latest available data before the index date)
To describe the demographic characteristics of patients
次要结局
- 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))
- MiniAQLQ(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))
- 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))