Clinical Outcome of Corticosteroids in the Treatment of COPD Exacerbations in China

NCT03633838 | Completed

• 1 other identifier: D589BR00037
• Study Type: observational
• Target: 5,067
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• The length of hospital stay(days)

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

  day 1 to up to 30 days (Hospital discharge)

• The rate of mortality

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

  day 1 to up to 30 days (Hospital discharge)

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

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

  day 1 to up to 30 days (Hospital discharge)

Secondary Outcomes (7)

• The rate of new-onset pneumonia during hospitalization

  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 weight

  day 1 to up to 30 days (Hospital discharge)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients with COPD exacerbations received hospitalization since September 2013

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 201000, China

Location

Study Officials

• Jinfu XU, Prof.

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: August 16, 2018
• Study Start: February 28, 2017
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

CN (1)