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临床试验/NCT04045587
NCT04045587招募中不适用

International Severe Asthma Registry: Canadian Cohort

University of British Columbia17 个研究点 分布在 1 个国家目标入组 714 人开始时间: 2018年11月6日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celine Bergeron

Principal Investigator

University of British Columbia

研究点 (17)

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