Clinical trial NCT02051166: Clinical Practice of AECOPD Management in China
Official title: A Non Interventional, Retrospective Study on AECOPD Treatment Status in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 5095
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage of glucocorticoids treatment for AECOPD
timeFrame: day 1 to up to 30 days (Hospital discharge)
Secondary outcomes:
measure: Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospital
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Mortality caused by AECOPD and recorded as primary cause of death by clinicians
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospital
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Endotracheal intubation rate in treatment of AECOPD
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Hospitalization duration and treatment cost due to AECOPD as primary cause
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Percentage of treatment category before AECOPD and at discharge
timeFrame: day 1 to up to 30 days (Hospital discharge)
measure: Clinical efficacy and safety within different administration route of corticosteroid treatment
timeFrame: day 1 to up to 30 days (Hospital discharge)
Other outcomes:
measure: Demographic data
timeFrame: day 1
measure: Year of COPD diagnosis
timeFrame: day 1
measure: Any other significant medical condition or co-morbidities
timeFrame: day 1
measure: Smoking status (number of pack-years)
timeFrame: day 1
measure: Onset date of this AECOPD, date of hospitalization, date of discharge
timeFrame: day 1 to up to 30 days (Hospital discharge)
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Langfang
country: China
facility: Research Site
state: Hebei
city: Baotou
country: China
facility: Research Site
state: Inner Mongolia
city: Hohhot
country: China
facility: Research Site
state: Inner Mongolia
city: Yinchuan
country: China
facility: Research Site
state: Ningxia
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Beijing
country: China
facility: Research Site
city: Guang Zhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: Peking University Third Hospital
name: Wanzhen Yao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.