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临床试验/NCT03633838
NCT03633838已完成不适用

Clinical Outcome of Corticosteroids in the Treatment of Chronic Obstructive Pulmonary Disease(COPD) Exacerbations in China (CONTAIN Study): Post-hoc Analysis of the Database of Acute Exacerbation of COPD Non-interventional Study

AstraZeneca1 个研究点 分布在 1 个国家目标入组 5,067 人开始时间: 2017年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
5,067
试验地点
1
主要终点
The change of FEV1(Forced Expiratory Volume in the first second) after treatment

研究概览

简要总结

This is a Post-hoc analysis based on the database of "A non-interventional, retrospective study on AECOPD treatment status in China". A large nation-wide retrospective non-interventional study has carried out from January to September 2014 in China. The study aimed to observe clinical practice including glucocorticoids treatment in AECOPD in China. The data for 5067 cases were collected. These cases met the following inclusion criteria: more than 40 years old, diagnosed by GOLD 2013 (GOLD: The Global Initiative for Chronic Obstructive Lung Disease) as COPD at least 3 months before AECOPD based on treating physician's judgment; the patients received hospitalization due to AECOPD since Sep 2013. Demographic information, administration of corticosteroids, medical and surgical history, comorbidities, clinical outcome, laboratory tests and lung function tests were recorded in database. There were 43 sites in the main study. These sites located in 22 provinces in China. A majority of sites (40 sites) were tier 3 hospitals in major cities. The data in study was provided by each site via medical records. In 5091 screening cases, 5067 cases were recruited and included in full analysis set (FAS). All cases in FAS will be included into this post-hoc analysis.

Through data mining and analysis, it is to explore the relationship between corticosteroids based treatment regimen and clinical outcome and the optimal treatment regimen for corticosteroids used in inpatients with COPD exacerbations based on our database.

详细描述

In general, the statistical analyses based on raw data and the data using propensity score matching (PSM) will be primarily descriptive in nature. The statistics are as in the following:

  • Continuous variables: N, mean, standard deviation, lower quartile Q1, median, upper quartile Q3, minimum, maximum;
  • Categorical variables: frequencies and percentages of patients at each category.

Before the statistical analyses, the medical history and co-morbidities need to be coded using ICD10. At the same time, the data collected should be clearly understood and provide the following information but not limited to the number of subjects enrolled in each site, the list of variables, the number of observations of each variable and the missing proportion of the variable.

The factors involved into the logistic model for propensity score matching include but not limited to demographic, baseline characteristics, severity of COPD, etc. A factor research will be performed before the matching is performed aiming to include appropriate factors into the model. Matching ratio could be exact or approximate.

Programming software is SAS 9.3 (SAS: Statistical Analysis System) or higher in Windows system. R statistical software could be another tool for the exploration.

研究设计

研究类型
Observational
观察模型
Other
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

  • 未提供

排除标准

  • The proportion of missing data for a variable at a specific site is too high to be concerned as highly variable or uncertain, then the data for this site will be excluded from the analysis.

结局指标

主要结局

The change of FEV1(Forced Expiratory Volume in the first second) after treatment

时间窗: day 1 to up to 30 days (Hospital discharge)

Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

The length of hospital stay(days)

时间窗: day 1 to up to 30 days (Hospital discharge)

Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

The rate of mortality

时间窗: day 1 to up to 30 days (Hospital discharge)

Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide(BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

次要结局

  • The COPD history(day 1 to up to 30 days (Hospital discharge))
  • The rate of new-onset pneumonia during hospitalization(day 1 to up to 30 days (Hospital discharge))
  • The weight(day 1 to up to 30 days (Hospital discharge))
  • The cost during hospitalization(day 1 to up to 30 days (Hospital discharge))
  • The age(day 1 to up to 30 days (Hospital discharge))
  • The sex(day 1 to up to 30 days (Hospital discharge))
  • The height(day 1 to up to 30 days (Hospital discharge))

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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