CClinicalTrials.gg
CompletedNCT02051166Updated Jun 15, 2016

Clinical Practice of AECOPD Management in China

An observational study in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 13 sites in China. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2016-06-15.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
5,095
Ages
40 Years to 95 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 5,095 is above the median of 150 across 639 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
5,095 participants (actual)
Patient registry
No
06

What researchers measure

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)

07

Study locations

13 sites
  • Research Site
    Hefei, Anhui, China
  • Research Site
    Beijing, Beijing, 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, China
  • Research Site
    Taiyuan, Shanxi, China
  • Research Site
    Xi'an, Shanxi, China
  • Research Site
    Beijing, China
  • Research Site
    Guang Zhou, China
  • Research Site
    Shanghai, China
  • Research Site
    Tianjin, China
08

References and documents

Publications

  • 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. PubMed 31819404 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02051166
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jan 31, 2014
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Jun 15, 2016

Study contacts

Wanzhen Yao, Ph.D
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion