International Severe Asthma Registry: Canadian Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 714
- 试验地点
- 17
- 主要终点
- Blood eosinophil counts
研究概览
简要总结
The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.
详细描述
Study staff will collect medical information through reviewing participant medical charts and interviewing participants about their health/asthma. The information collected includes birth date, gender, ethnicity, height/weight, body mass index, medical history (smoking history and exacerbation history), current and past asthma related medications, and any recent test results available pertaining to blood work, lung function, allergen skin prick, and imaging. This information will be collected at the baseline visit, and then once a year at a follow up visit, for five years (total of five visits).
Participants will be assigned a unique study number to protect the confidentiality of their personal health care information. All study data will be de-identified and then stored in a secure information management system, hosted at the study sponsor, Optimum Patient Care Global Limited in Cambridge, United Kingdom. Participant identities will always be kept confidential and will not be included in any research that is published. Data collected across the Canadian sites will be used to find ways to improve asthma treatments in Canada, to report on current patterns of managing severe asthma in Canada, to identify different sub-groups of severe asthma, and to carry out various medical research to understand asthma better and develop new treatments.
Research records and health or other source records may be inspected in the presence of the Principal Investigator or by representatives of the University of British Columbia's Clinical Research Ethics Board for the purpose of monitoring the research. No information or records that disclose participants' identities will be published without subject consent, nor will any information or records that disclose participants' identities be removed or released without subject consent unless required by law.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18 years or older
- •Participants receiving treatment according to GINA Step 5 or uncontrolled in GINA Step 4 (uncontrolled is defined as having severe asthma symptoms or frequent exacerbations)
排除标准
- •Participants with mild to moderate asthma
研究组 & 干预措施
Severe Asthma Participants
Participants with severe asthma classified at GINA Step 4 and uncontrolled in terms of their symptoms and exacerbations or GINA Step 5.
结局指标
主要结局
Blood eosinophil counts
时间窗: Past 12 months
10\^9/L
Fractional exhaled nitric oxide level
时间窗: Past 12 months
parts per billion
Asthma Control
时间窗: Past 4 weeks
Assessed through the Global Initiative for Asthma (GINA) Questionnaire
Number of emergency room visits for asthma
时间窗: Past 12 months
Total number of visits
Spirometry test results for Forced Vital Capacity (FVC)
时间窗: Past 12 months
Pre- and post-bronchodilator FVC results in litres
Start and end dates of oral corticosteroid medication
时间窗: Prior to baseline visit
Day/Month/Year for start and end dates if available
Blood Immunoglobulin E (IgE) counts
时间窗: Past 12 months
kilo unit/L
Reason for switching biologic medication (if relevant)
时间窗: Past 12 months
Options include: lack of clinical efficacy, side effects, biologic access restriction, and patient preference
Number of hospital admissions for asthma
时间窗: Past 12 months
Total number of admissions
Start and end dates of biologic medications such as anti-interleukin-5, anti-immunoglobulin E, or anti-interleukin-4 treatments (if relevant)
时间窗: Prior to baseline visit
Day/Month/Year for start and end dates if available
Start and end dates of all asthma related inhaled medications
时间窗: Prior to baseline visit
Day/Month/Year for start and end dates if available
Number of asthma exacerbations requiring rescue steroids
时间窗: Past 12 months
Severe asthma exacerbations are defined as events that require urgent action (rescue steroids) by the participant and physician to prevent a serious outcome
Spirometry test results for Forced Expiratory Volume in One Second (FEV1)
时间窗: Past 12 months
Pre- and post-bronchodilator FEV1 results in litres
次要结局
未报告次要终点
研究者
Celine Bergeron
Principal Investigator
University of British Columbia
