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临床试验/NCT05903989
NCT05903989
已完成
不适用

A Secondary Database Study Using COPD Cohort Study in Japan to Investigate Health Status of COPD Patients With Different Inhaler Treatment

AstraZeneca1 个研究点 分布在 1 个国家目标入组 708 人2023年9月11日
适应症COPD

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
COPD
发起方
AstraZeneca
入组人数
708
试验地点
1
主要终点
Proportion of patients with CAT (≥10, <10) at registration in each inhaler treatment group (Long acting muscarinic antagonist(LAMA), LAMA+Long acting β2 agonist(LABA) or Inhaled corticosteroid(ICS) +LABA)
状态
已完成
最后更新
去年

概览

简要总结

This retrospective observational study aims to report distribution of the proportion of symptomatic Chronic obstructive pulmonary disease (COPD) patients classified by the COPD Assessment Test (CAT) managed with single or dual inhaler treatment using the data at cohort entry in the COPD cohort study, and treatment change and longitudinal CAT score by each inhaler treatment will also be evaluated using the data during the follow-up period.

注册库
clinicaltrials.gov
开始日期
2023年9月11日
结束日期
2023年10月24日
最后更新
去年
研究类型
Observational
性别
All

研究者

发起方
AstraZeneca
责任方
Sponsor

入排标准

入选标准

  • Patients taken with any of following inhaler treatments; LAMA, LAMA+LABA(both single and dual inhaler) or ICS+LABA(both single and dual inhaler) at cohort entry

排除标准

  • Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study

结局指标

主要结局

Proportion of patients with CAT (≥10, <10) at registration in each inhaler treatment group (Long acting muscarinic antagonist(LAMA), LAMA+Long acting β2 agonist(LABA) or Inhaled corticosteroid(ICS) +LABA)

时间窗: At registration

To describe the proportion of symptomatic(CAT ≥10) and non-symptomatic(CAT\<10) COPD patients in each of 3 different inhaler treatment categories(LAMA, LAMA+LABA or ICS+LABA) at registration

次要结局

  • Proportion of patients with changes of inhaler treatment categories (step up or all other categories) during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration(1 year follow-up)
  • Mean change in the CAT scores between at registration and 1 year follow-up in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration(1 year follow-up)
  • Proportion of patients with all patterns of inhaler treatment category changes during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration(1 year follow-up)
  • Proportion of patients with CAT (≥10, <10) after 1 year follow-up by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration(1 year follow-up)

研究点 (1)

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