Clinical Practice of AECOPD Management in China

Completed

• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02051166
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5095

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of glucocorticoids treatment for AECOPD	day 1 to up to 30 days (Hospital discharge)

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tianjin, China