Clinical Practice of AECOPD Management in China

NCT ID: NCT02051166

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5095 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-08-31

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanzhen Yao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Research Site

Hefei, Anhui, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Langfang, Hebei, China

Research Site

Baotou, Inner Mongolia, China

Research Site

Hohhot, Inner Mongolia, China

Research Site

Yinchuan, Ningxia, China

Research Site

Shanghai, Shanghai Municipality, China

Research Site

Taiyuan, Shanxi, China

Research Site

Xi’an, Shanxi, China

Research Site

Beijing, , China

Research Site

Guangzhou, , China

Research Site

Shanghai, , China

Research Site

Tianjin, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31819404 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2815&filename=NIS-RCN-XXX-2013_1_CSR_Synopsis.pdf

CSR Synopsis

http://onlinelibrary.wiley.com/doi/10.1111/resp.12706/epdf

Yao et al AECOPD NIS abstract\_2015 APSR abstract ID: 285

Other Identifiers

NIS-RCN-XXX-2013/1

Identifier Type: -

Identifier Source: org_study_id