此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Symptoms and Physical Activity in COPD Patients in Europe (SPACE)

2017年9月29日 更新者:AstraZeneca
An observational, multinational, cross sectional study to describe 24-hs symptoms, physical activity and their relationship in stable COPD patients in Europe

研究概览

地位

完全的

详细说明

The study is a multi-centre, multi country, observational prospective cross sectional study to determine the prevalence and severity of early morning, day and night-time symptoms and physical activity patterns and to evaluate their correlation between each other and with disease severity, adherence to respiratory medications, direct costs and PROs in patients with stable COPD in Europe.

Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected countries.

研究类型

观察性的

注册 (实际的)

2176

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 130年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Male and female ambulatory patients aged over 40 years diagnosed with stable COPD according 2013 GOLD criteria

描述

Inclusion Criteria:

  1. Male or female patients aged 40 years or older.
  2. Patient has diagnosis of COPD for 1 year or more.
  3. Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post BD, in previous 12 months
  4. Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack- years.
  5. Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
  6. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
  7. After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

  1. Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases. (except for non-idiopathic pulmonary fibrosis and ACOS, only if the main diagnosis is COPD)
  2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
  3. Patient is participating in an ongoing clinical trial that might, in the investigator's opinion, influence the assessment for SPACE study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting.
大体时间:Day 1
Day 1

次要结果测量

结果测量
大体时间
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1
大体时间:Day 1
Day 1
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
大体时间:Day 1
Day 1
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1
大体时间:Day 1
Day 1
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1
大体时间:Day 1
Day 1
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1
大体时间:Day 1
Day 1
• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months
大体时间:Day 1
Day 1
• Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
大体时间:Day 1
Day 1
• Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1
大体时间:Day 1
Day 1
• Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1
大体时间:Day 1
Day 1
• Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1
大体时间:Day 1
Day 1
• Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months
大体时间:Day 1
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Florin D Mihaltan, MD,PhD、Institute Marius Nasta, Bucharest

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月21日

初级完成 (实际的)

2017年8月31日

研究完成 (实际的)

2017年8月31日

研究注册日期

首次提交

2016年12月20日

首先提交符合 QC 标准的

2017年1月23日

首次发布 (估计)

2017年1月26日

研究记录更新

最后更新发布 (实际的)

2017年10月2日

上次提交的符合 QC 标准的更新

2017年9月29日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • D5970R00006

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

慢性阻塞性肺病的临床试验

3
订阅