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Clinical Outcome of Corticosteroids in the Treatment of COPD Exacerbations in China (CONTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633838
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

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.


Condition or disease
Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 5067 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The length of hospital stay(days) [ Time Frame: 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)

  2. The rate of mortality [ Time Frame: 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)

  3. The change of FEV1(Forced Expiratory Volume in the first second) after treatment [ Time Frame: 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)


Secondary Outcome Measures :
  1. The rate of new-onset pneumonia during hospitalization [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the rate of new-onset pneumonia during hospitalization among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  2. The cost during hospitalization [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the hospitalization cost among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  3. The age [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate demographic characteristics among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  4. The sex [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  5. The weight [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  6. The height [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)

  7. The COPD history [ Time Frame: day 1 to up to 30 days (Hospital discharge) ]
    Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients with COPD exacerbations received hospitalization since September 2013
Criteria

Inclusion criteria:

  • Inpatients with COPD exacerbations who received Nebulized Budesonide(Neb. BUD), Systemic corticosteroids(SCS) and Neb. BUD combined with SCS treatment in 5067 cases of database were included.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633838


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 201000
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Jinfu XU, Prof. Shanghai Pulmonary Hospital, Shanghai, China
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03633838    
Other Study ID Numbers: D589BR00037
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases