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临床试验/NCT06053541
NCT06053541已完成不适用

Hospitalization, Mortality Rates and Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) in Distrito Federal, Brazil, Before and After the Change in 2018 State COPD Protocol Version - Real-world Data

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 3,015,000 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,015,000
试验地点
1
主要终点
Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients

研究概览

简要总结

This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in Brazil.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 40 years of age at the time of hospital admission
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by the Health Care Protocol of the Health Secretariat of Federal District (SES/DF), with the following codes:
  • J41.0 - Simple chronic bronchitis
  • J41.1 - Mucopurulent chronic bronchitis
  • J41.8 - Mixed simple and mucopurulent chronic bronchitis
  • J42 - Unspecified chronic bronchitis
  • J43.1 - Panlobular emphysema
  • J43.2 - Centrilobular emphysema
  • J43.8 - Other emphysema
  • J43.9 - Emphysema, unspecified
  • J44.0 - Chronic obstructive pulmonary disease with acute lower respiratory infection
  • J44.1 - Chronic obstructive pulmonary disease with acute exacerbation, unspecified
  • J44.8 - Other specified chronic obstructive pulmonary disease
  • J44.9 - Chronic obstructive pulmonary disease, unspecified

排除标准

  • Patients younger than 40 yeas of age at the time of hospital admission

结局指标

主要结局

Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients

时间窗: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.

Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients

时间窗: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year.

Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

时间窗: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Total accumulated costs to the payer per year associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations, is reported, the same patient could have been hospitalized more than once a year. No individual costs, the cost reported are the total spent per year.

Infirmary Beds

时间窗: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Average monthly number of available Infirmary beds, including available general and ICU (Intensive care unit) beds are reported, the same patient could have been hospitalized more than once a year.

次要结局

  • Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations(From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.)
  • Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)(From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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