Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT02051166
Clinical Practice of AECOPD Management in China
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 13 sites in China.
Trial summary
The purpose of this study is observe clinical practice including glucocorticoids treatment in AECOPD in China. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- How many people
- 5,095 participants
- Where
- 13 sitesChina
- Study dates
- Feb 2014to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Research Site
Baotou, Inner Mongolia
Research Site
Beijing, Beijing Municipality
Research Site
Beijing
Research Site
Guangzhou
Research Site
Hefei, Anhui
Research Site
Hohhot, Inner Mongolia
Research Site
Langfang, Hebei
Research Site
Shanghai, Shanghai Municipality
Research Site
Shanghai
Research Site
Taiyuan, Shanxi
Research Site
Tianjin
Research Site
Xi’an, Shanxi
Research Site
Yinchuan, Ningxia
About this study
Official title: A Non Interventional, Retrospective Study on AECOPD Treatment Status in China
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glucocorticoids treatment for AECOPD
Measured: day 1 to up to 30 days (Hospital discharge)
Secondary outcomes (9)
Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospital
Measured: day 1 to up to 30 days (Hospital discharge)
Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.
Measured: day 1 to up to 30 days (Hospital discharge)
Mortality caused by AECOPD and recorded as primary cause of death by clinicians
Measured: day 1 to up to 30 days (Hospital discharge)
Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospital
Measured: day 1 to up to 30 days (Hospital discharge)
Endotracheal intubation rate in treatment of AECOPD
Measured: day 1 to up to 30 days (Hospital discharge)
Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD
Measured: day 1 to up to 30 days (Hospital discharge)
Hospitalization duration and treatment cost due to AECOPD as primary cause
Measured: day 1 to up to 30 days (Hospital discharge)
Percentage of treatment category before AECOPD and at discharge
Measured: day 1 to up to 30 days (Hospital discharge)
Clinical efficacy and safety within different administration route of corticosteroid treatment
Measured: day 1 to up to 30 days (Hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 5,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wanzhen Yao, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051166
- Sponsor's protocol ID
- NIS-RCN-XXX-2013/1
- Status last verified
- Jun 2016
- First submitted
- 24 Jan 2014
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Interventional, Retrospective Study on AECOPD Treatment Status in China
- ClinicalTrials.gov ID
- NCT02051166
- Acronym / sponsor ID
- NIS-RCN-XXX-2013/1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,095 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of glucocorticoids treatment for AECOPD
Time frame: day 1 to up to 30 days (Hospital discharge)
9 secondary outcomes
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)
Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.
Time frame: day 1 to up to 30 days (Hospital discharge)
Mortality caused by AECOPD and recorded as primary cause of death by clinicians
Time frame: day 1 to up to 30 days (Hospital discharge)
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)
Endotracheal intubation rate in treatment of AECOPD
Time frame: day 1 to up to 30 days (Hospital discharge)
Pneumonia rate at the diagnose of AECOPD and in treatment of AECOPD
Time frame: day 1 to up to 30 days (Hospital discharge)
Hospitalization duration and treatment cost due to AECOPD as primary cause
Time frame: day 1 to up to 30 days (Hospital discharge)
Percentage of treatment category before AECOPD and at discharge
Time frame: day 1 to up to 30 days (Hospital discharge)
Clinical efficacy and safety within different administration route of corticosteroid treatment
Time frame: day 1 to up to 30 days (Hospital discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Derived from this study: PubMed 31819404Zheng 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.
- CSR SynopsisLink provided by the sponsor.
Related trials for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanzhen Yao, Ph.D principal investigator
Peking University Third Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of glucocorticoids treatment for AECOPD (time frame: day 1 to up to 30 days (Hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.