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Completed

NCT Number: NCT02051166

Clinical Practice of AECOPD Management in China

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

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Key information

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥40 years old
  • Hospitalization treatment due to AECOPD since Sep, 2013
  • Diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician's judgment
  • Provided informed consent or informed consent waiver

Exclusion criteria

  • Participation in any interventional clinical study within 3 months before being recruited in the study.
  • Ongoing AECOPD during recruitment timeline
  • The patients whose symptoms haven't recovered and then discharge by themselves
  • The primary diagnosis of hospitalization is not AECOPD

Treatment and study plan

Primary outcomes

  1. Percentage of glucocorticoids treatment for AECOPD

    Time frame: day 1 to up to 30 days (Hospital discharge)

Secondary outcomes

  1. Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospital

    Time frame: day 1 to up to 30 days (Hospital discharge)

  2. Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.

    Time frame: day 1 to up to 30 days (Hospital discharge)

  3. Mortality caused by AECOPD and recorded as primary cause of death by clinicians

    Time frame: day 1 to up to 30 days (Hospital discharge)

  4. Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospital

    Time frame: day 1 to up to 30 days (Hospital discharge)

  5. Endotracheal intubation rate in treatment of AECOPD

    Time frame: day 1 to up to 30 days (Hospital discharge)

  6. Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD

    Time frame: day 1 to up to 30 days (Hospital discharge)

  7. Hospitalization duration and treatment cost due to AECOPD as primary cause

    Time frame: day 1 to up to 30 days (Hospital discharge)

  8. Percentage of treatment category before AECOPD and at discharge

    Time frame: day 1 to up to 30 days (Hospital discharge)

  9. Clinical efficacy and safety within different administration route of corticosteroid treatment

    Time frame: day 1 to up to 30 days (Hospital discharge)

Other outcomes

  1. Demographic data

    Time frame: day 1

  2. Year of COPD diagnosis

    Time frame: day 1

  3. Any other significant medical condition or co-morbidities

    Time frame: day 1

  4. Smoking status (number of pack-years)

    Time frame: day 1

  5. Onset date of this AECOPD, date of hospitalization, date of discharge

    Time frame: day 1 to up to 30 days (Hospital discharge)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2014
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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