Pulmonary Disease, Chronic ObstructiveNCT05032898
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
An observational study of Pulmonary Disease, Chronic Obstructive, run by China-Japan Friendship Hospital.
Trial summary
The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2023
- How long will I take part?
- 1 Year
- 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: Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease will be consecutively recruited from target hospitals.
Who may be able to join
- ≥18 years of age
- hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Who cannot join
- refusing to sign informed consent forms
- participating in clinical trials or intervention studies of drugs
- diagnosed as active pulmonary tuberculosis, or acute left heart failure
Trial locations and contacts
No sites are listed yet.
Chen Wang, Doctor contact
About this study
The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Read the detailed description
Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Eligibility Criteria: Details are shown in the Eligibility Criteria part.
Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- registries, demography, therapeutics, disease management, mortality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause in-hospital mortality
All-cause mortality during hospitalization
Measured: From date of admission to date of discharge, an expected median of 10 days
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge
Measured: 30 days after day of discharge
Secondary outcomes (10)
All-cause mortality
All-cause mortality during follow-ups
Measured: 30 days and 1 year after day of discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge
Measured: 1 year after day of discharge
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during follow-ups
Measured: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second (L)
Post-bronchodilator forced expiratory volume in one second (L) during follow-ups
Measured: 30 days, 1 year after day of discharge
Predicted post-bronchodilator forced expiratory volume in one second (%)
Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups
Measured: 30 days, 1 year after day of discharge
Post-bronchodilator forced vital capacity (L)
Post-bronchodilator forced vital capacity (L) during follow-ups
Measured: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second to forced vital capacity
Post-bronchodilator forced expiratory volume in one second to forced vital capacity during follow-ups
Measured: 30 days, 1 year after day of discharge
Chronic obstructive pulmonary disease assessment test (CAT) score
Chronic obstructive pulmonary disease assessment test (CAT) score at day of discharge and during follow-ups. CAT is an 8-item questionnaire used to measure the impact of respiratory disease on patients' health status. The score of CAT ranges from 0 to 40, with 0 indicating the best health status while 40 as the worst.
Measured: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Modified medical research council (mMRC) dyspnea scale
Modified medical research council (mMRC) dyspnea scale at day of discharge and during follow-ups. mMRC includes 5 grades (0, 1, 2, 3 and 4), where higher grade reflects worse health-related quality of life and higher symptom burden.
Measured: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Direct total cost of chronic obstructive pulmonary disease management
Direct total cost of chronic obstructive pulmonary disease management during hospitalization and follow-ups.
Measured: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Wang, China-Japan Friendship Hospital
- Investigators
- Chen Wang, Doctor, Study chair, Institue of Basic Medical Sciences Chinese Academy of Medical SciencesTing Yang, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032898
- Sponsor's protocol ID
- AECOPD-IRS-II
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results (text, tables, figures, and appendices) reported in the publication of summary data, study protocol, statistical analysis plan (SAP), analytic code will be shared from 1 to 3 years following the completion of data cleaning. All above could be shared with researches who provide a methodologically sound and feasible proposal approved by principal investigator (email address: cyh-birm@263.net, dryangting@qq.com) and a signed data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. 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 Stage II
- ClinicalTrials.gov ID
- NCT05032898
- Acronym / sponsor ID
- AECOPD-IRS-II
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- registries, demography, therapeutics, disease management, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Sep 2021 (actual)
- 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 aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Detailed description
Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Eligibility Criteria: Details are shown in the Eligibility Criteria part.
Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease will be consecutively recruited from target hospitals.
Key inclusion criteria (2 listed)
- ≥18 years of age
- hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Key exclusion criteria (3 listed)
- refusing to sign informed consent forms
- participating in clinical trials or intervention studies of drugs
- diagnosed as active pulmonary tuberculosis, or acute left heart failure
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
All-cause in-hospital mortality
Time frame: From date of admission to date of discharge, an expected median of 10 days
All-cause mortality during hospitalization
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge
Time frame: 30 days after day of discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge
10 secondary outcomes
All-cause mortality
Time frame: 30 days and 1 year after day of discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge
Time frame: 1 year after day of discharge
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second (L)
Time frame: 30 days, 1 year after day of discharge
Predicted post-bronchodilator forced expiratory volume in one second (%)
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced vital capacity (L)
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second to forced vital capacity
Time frame: 30 days, 1 year after day of discharge
Chronic obstructive pulmonary disease assessment test (CAT) score
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Modified medical research council (mMRC) dyspnea scale
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Direct total cost of chronic obstructive pulmonary disease management
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results (text, tables, figures, and appendices) reported in the publication of summary data, study protocol, statistical analysis plan (SAP), analytic code will be shared from 1 to 3 years following the completion of data cleaning. All above could be shared with researches who provide a methodologically sound and feasible proposal approved by principal investigator (email address: cyh-birm@263.net, dryangting@qq.com) and a signed data access agreement.
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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.
Chen Wang, Doctor contact
Chen Wang, Doctor study chair
Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
Ting Yang, Doctor principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, 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 2 inclusion and 3 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 2 Sep 2021. 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?
Contact Ting Yang, Doctor (13651380809, dryangting@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause in-hospital mortality (time frame: From date of admission to date of discharge, an expected median of 10 days). 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?
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 2 Sep 2021.