Skip to content

Clinical Practice of AECOPD Management in China

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02051166
Enrollment
5095
Registered
2014-01-31
Start date
2014-02-28
Completion date
2014-08-31
Last updated
2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Brief summary

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

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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of glucocorticoids treatment for AECOPDday 1 to up to 30 days (Hospital discharge)

Secondary

MeasureTime frame
Mortality caused by AECOPD and recorded as primary cause of death by cliniciansday 1 to up to 30 days (Hospital discharge)
Endotracheal intubation rate in treatment of AECOPDday 1 to up to 30 days (Hospital discharge)
Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPDday 1 to up to 30 days (Hospital discharge)
Hospitalization duration and treatment cost due to AECOPD as primary causeday 1 to up to 30 days (Hospital discharge)
Percentage of treatment category before AECOPD and at dischargeday 1 to up to 30 days (Hospital discharge)
Clinical efficacy and safety within different administration route of corticosteroid treatmentday 1 to up to 30 days (Hospital discharge)
Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospitalday 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)
Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospitalday 1 to up to 30 days (Hospital discharge)

Other

MeasureTime frame
Any other significant medical condition or co-morbiditiesday 1
Smoking status (number of pack-years)day 1
Onset date of this AECOPD, date of hospitalization, date of dischargeday 1 to up to 30 days (Hospital discharge)
Demographic dataday 1
Year of COPD diagnosisday 1

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026