Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 1
- 主要终点
- Number of severe asthma patients eligible for one or more biologic treatments for asthma
研究概览
简要总结
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •At least 12 years of age at study visit.
- •Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).
- •Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).
- •SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.
- •Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).
排除标准
- •Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
研究组 & 干预措施
Non-drug interventional group
All enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires. No investigational product will be administered to participants.
干预措施: Short Acting Beta Agonist (SABA) (Drug)
结局指标
主要结局
Number of severe asthma patients eligible for one or more biologic treatments for asthma
时间窗: Day 1
Biologic treatments for asthma will include mepolizumab (anti-Interleukin \[IL\] 5), omalizumab (anti-immunoglobulin E \[IgE\]), and reslizumab (anti-IL5).
次要结局
- Mean post-bronchodilator FVC(Day 1)
- Mean and median Charlson Comorbidity Index score(Day 1)
- Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)(Day 1)
- Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)(Day 1)
- Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months(Day 1)
- Mean post-bronchodilator FEV1/FVC ratio(Day 1)
- Mean pre-bronchodilator FEV1(Day 1)
- Mean post-bronchodilator FEV1(Day 1)
- Mean pre-bronchodilator FVC(Day 1)
- Mean and median levels of blood eosinophils(Day 1)
- Mean and median levels of total IgE(Day 1)
- Mean and median levels of specific IgE(Day 1)
- Descriptive statistics for EuroQol 5D (EQ-5D-5L)(Day 1)
- Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio(Day 1)
- Descriptive statistics for asthma Control Questionnaire (ACQ-5)(Day 1)
- Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)(Day 1)
- Descriptive statistics for Asthma Symptom Utility Index (ASUI)(Day 1)