Clinical Practice of AECOPD Management in China

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051166
• Other study ID #: NIS-RCN-XXX-2013/1
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: June 14, 2016
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5095
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Research Site	Baotou	Inner Mongolia
China	Research Site	Beijing	Beijing
China	Research Site	Beijing
China	Research Site	Guang Zhou
China	Research Site	Hefei	Anhui
China	Research Site	Hohhot	Inner Mongolia
China	Research Site	Langfang	Hebei
China	Research Site	Shanghai
China	Research Site	Shanghai	Shanghai
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin
China	Research Site	Xi'an	Shanxi
China	Research Site	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic data		day 1	No
Other	Year of COPD diagnosis		day 1	No
Other	Any other significant medical condition or co-morbidities		day 1	No
Other	Smoking status (number of pack-years)		day 1	No
Other	Onset date of this AECOPD, date of hospitalization, date of discharge		day 1 to up to 30 days (Hospital discharge)	No
Primary	Percentage of glucocorticoids treatment for AECOPD		day 1 to up to 30 days (Hospital discharge)	No
Secondary	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)	No
Secondary	Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.		day 1 to up to 30 days (Hospital discharge)	No
Secondary	Mortality caused by AECOPD and recorded as primary cause of death by clinicians		day 1 to up to 30 days (Hospital discharge)	No
Secondary	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)	No
Secondary	Endotracheal intubation rate in treatment of AECOPD		day 1 to up to 30 days (Hospital discharge)	No
Secondary	Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD		day 1 to up to 30 days (Hospital discharge)	No
Secondary	Hospitalization duration and treatment cost due to AECOPD as primary cause		day 1 to up to 30 days (Hospital discharge)	No
Secondary	Percentage of treatment category before AECOPD and at discharge		day 1 to up to 30 days (Hospital discharge)	No
Secondary	Clinical efficacy and safety within different administration route of corticosteroid treatment		day 1 to up to 30 days (Hospital discharge)	No

External Links

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