Clinical Practice of AECOPD Management in China

A Non Interventional, Retrospective Study on AECOPD Treatment Status in China

The purpose of this study is observe clinical practice including glucocorticoids treatment in AECOPD in China.

Study Overview

• Status: Completed
• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Detailed Description

It is widely recognized that the global social and economic burden of Chronic obstructive pulmonary disease (COPD) is high; affecting an estimated 64 million people worldwide. It was reported the prevalence of COPD in China population over 40 years old is about 8.2% (Zhong Nanshan et al, 2007). According to the report on China Chronic Disease, COPD is the second disease of Disability Adjusted Life Years. The economic burden of COPD is tremendous in China. Cost analysis in 2006 showed that every COPD patient in urban would pay 1732.24 $ on medical cost every year, indirect cost on nurse and traffic is 231.6 $, total cost would account for 40% of average family income in 2006(Chiang CH.,2008).AECOPD is one of most important cause leading to COPD death. Corticosteroid is essential for AECOPD management and recommended by domestic and international guidelines. But it shows that corticosteroid use for treating AECOPD in China is around 70% from market research in big hospitals, and less report about how steroid is used for AECOPD management was published, including distribution, dosage, treatment duration, etc. The healthcare resources utilization for treating AECOPD in China is also unclear.

• Study Type: Observational
• Enrollment (Actual): 5095

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Guang Zhou, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Tianjin, China
    • Research Site
  • Anhui
    • Hefei, Anhui, China
      • Research Site
  • Beijing
    • Beijing, Beijing, China
      • Research Site
  • Hebei
    • Langfang, Hebei, China
      • Research Site
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Research Site
    • Hohhot, Inner Mongolia, China
      • Research Site
  • Ningxia
    • Yinchuan, Ningxia, China
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China
      • Research Site
  • Shanxi
    • Taiyuan, Shanxi, China
      • Research Site
    • Xi'an, Shanxi, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population will be ≥40 years of age, received hospitalization due to AECOPD since Sep, 2013. The patients should be diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician judgment.

Description

Inclusion Criteria:

1. ≥40 years old
2. Hospitalization treatment due to AECOPD since Sep, 2013
3. Diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician's judgment
4. Provided informed consent or informed consent waiver

Exclusion Criteria:

1. Participation in any interventional clinical study within 3 months before being recruited in the study.
2. Ongoing AECOPD during recruitment timeline
3. The patients whose symptoms haven't recovered and then discharge by themselves
4. The primary diagnosis of hospitalization is not AECOPD

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of glucocorticoids treatment for AECOPD	day 1 to up to 30 days (Hospital discharge)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospital	day 1 to up to 30 days (Hospital discharge)
Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.	day 1 to up to 30 days (Hospital discharge)
Mortality caused by AECOPD and recorded as primary cause of death by clinicians	day 1 to up to 30 days (Hospital discharge)
Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospital	day 1 to up to 30 days (Hospital discharge)
Endotracheal intubation rate in treatment of AECOPD	day 1 to up to 30 days (Hospital discharge)
Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD	day 1 to up to 30 days (Hospital discharge)
Hospitalization duration and treatment cost due to AECOPD as primary cause	day 1 to up to 30 days (Hospital discharge)
Percentage of treatment category before AECOPD and at discharge	day 1 to up to 30 days (Hospital discharge)
Clinical efficacy and safety within different administration route of corticosteroid treatment	day 1 to up to 30 days (Hospital discharge)

Other Outcome Measures

Outcome Measure	Time Frame
Demographic data	day 1
Year of COPD diagnosis	day 1
Any other significant medical condition or co-morbidities	day 1
Smoking status (number of pack-years)	day 1
Onset date of this AECOPD, date of hospitalization, date of discharge	day 1 to up to 30 days (Hospital discharge)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Wanzhen Yao, Ph.D, Peking University Third Hospital

Publications and helpful links

General Publications

• Zheng JP, Zhang J, Ma LJ, Chen P, Huang M, Ou XM, Zhao ZW, Jiang SJ, Cao J, Yao W. Clinical Outcomes Of Using Nebulized Budesonide As The Initial Treatment For Acute Exacerbations Of Chronic Obstructive Pulmonary Disease: A Post-Hoc Analysis. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2725-2731. doi: 10.2147/COPD.S196615. eCollection 2019.

Helpful Links

• CSR Synopsis
• Yao et al AECOPD NIS abstract_2015 APSR abstract ID: 285

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (ESTIMATE): January 31, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 15, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NIS-RCN-XXX-2013/1