Chronic Obstructive Pulmonary DiseaseAECOPD-IRSNCT02657525
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
Trial summary
The purpose of this study is to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 7,600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2020
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AECOPD-IRS plans to enroll 7600 hospitalized patients (≥ 18 years old with main diagnosis as AECOPD). Sample size estimation is based on estimated mortality of AECOPD hospitalized patients (~5%). Study patients will be recruited from 40-60 hospitals across China,each hospital will recruit 152-190 patients. Hospital selection follows a multi-stage sampling strategy.
Who may be able to join
- ≥18 years of age; hospitalized patients with main diagnosis as AECOPD.
Who cannot join
- Patients diagnosed as active pulmonary tuberculosis, or acute left heart failure; Patients participating in clinical trials or intervention studies of drugs.
About this study
The purpose of this study is to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
All-cause and cause-specific mortality will be described.
Measured: 12 months
Readmission
Readmission rate caused by AECOPD within 1 month after discharged from hospital.
Measured: 12 months
Secondary outcomes (4)
All-cause and cause-specific mortality
All-cause and cause-specific mortality will be described at different time points (1, 2, 3 years)
Measured: 3 years
Recurrence of acute exacerbation of COPD
Frequency of AECOPD recurrence will be described during follow-ups, the date of first recurrence after discharge will be analysed.
Measured: 3 years
Lung function and quality of life assessment
Lung function will be measured regularly, quality of life will be assessed by questionnaires
Measured: 3 years
Healthcare costs
Direct costs of hospital stay will be recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 7,600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, China Soong Ching Ling Foundation
- Responsible party
- Principal investigator, Chen Wang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657525
- Sponsor's protocol ID
- 2015-88
- Acronym
- AECOPD-IRS
- Status last verified
- Feb 2016
- First submitted
- 14 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ren X, He R, Xu Z, Xin Y, Wang Y, Yang T, Wang C. Effects of glucocorticoid administration routes on patients with acute exacerbations of chronic obstructive pulmonary disease in China: A propensity score-matched longitudinal analysis. Chin Med J (Engl). 2026 Mar 5;139(5):689-698. doi: 10.1097/CM9.0000000000003451. Epub 2025 Mar 4.
PubMed 40033752Niu Y, Niu H, Meng X, Zhu Y, Ren X, He R, Wu H, Yu T, Zhang Y, Kan H, Chen R, Yang T, Wang C. Associations Between Air Pollution and the Onset of Acute Exacerbations of COPD: A Time-Stratified Case-Crossover Study in China. Chest. 2024 Nov;166(5):998-1009. doi: 10.1016/j.chest.2024.05.030. Epub 2024 Jun 19.
PubMed 38906462He R, Wang Y, Ren X, Huang K, Lei J, Niu H, Li W, Dong F, Li B, Yang T, Wang C. Associations of medication regimen complexity with medication adherence and clinical outcomes in patients with chronic obstructive pulmonary disease: a prospective study. Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231206249. doi: 10.1177/17534666231206249.
PubMed 37855117
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study
- ClinicalTrials.gov ID
- NCT02657525
- Acronym / sponsor ID
- AECOPD-IRS / 2015-88
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,600 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University, China Soong Ching Ling Foundation
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Jan 2016 (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 to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AECOPD-IRS plans to enroll 7600 hospitalized patients (≥ 18 years old with main diagnosis as AECOPD). Sample size estimation is based on estimated mortality of AECOPD hospitalized patients (~5%). Study patients will be recruited from 40-60 hospitals across China,each hospital will recruit 152-190 patients. Hospital selection follows a multi-stage sampling strategy.
Key inclusion criteria (1 listed)
- ≥18 years of age; hospitalized patients with main diagnosis as AECOPD.
Key exclusion criteria (1 listed)
- Patients diagnosed as active pulmonary tuberculosis, or acute left heart failure; Patients participating in clinical trials or intervention studies of drugs.
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
In-hospital mortality
Time frame: 12 months
All-cause and cause-specific mortality will be described.
Readmission
Time frame: 12 months
Readmission rate caused by AECOPD within 1 month after discharged from hospital.
4 secondary outcomes
All-cause and cause-specific mortality
Time frame: 3 years
Recurrence of acute exacerbation of COPD
Time frame: 3 years
Lung function and quality of life assessment
Time frame: 3 years
Healthcare costs
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 40033752Ren X, He R, Xu Z, Xin Y, Wang Y, Yang T, Wang C. Effects of glucocorticoid administration routes on patients with acute exacerbations of chronic obstructive pulmonary disease in China: A propensity score-matched longitudinal analysis. Chin Med J (Engl). 2026 Mar 5;139(5):689-698. doi: 10.1097/CM9.0000000000003451. Epub 2025 Mar 4.
- Derived from this study: PubMed 38906462Niu Y, Niu H, Meng X, Zhu Y, Ren X, He R, Wu H, Yu T, Zhang Y, Kan H, Chen R, Yang T, Wang C. Associations Between Air Pollution and the Onset of Acute Exacerbations of COPD: A Time-Stratified Case-Crossover Study in China. Chest. 2024 Nov;166(5):998-1009. doi: 10.1016/j.chest.2024.05.030. Epub 2024 Jun 19.
- Derived from this study: PubMed 37855117He R, Wang Y, Ren X, Huang K, Lei J, Niu H, Li W, Dong F, Li B, Yang T, Wang C. Associations of medication regimen complexity with medication adherence and clinical outcomes in patients with chronic obstructive pulmonary disease: a prospective study. Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231206249. doi: 10.1177/17534666231206249.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
In-hospital mortality (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02657525, which also lists 3 linked publications.
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 4 Feb 2016.