Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseCONTAINNCT03633838
Clinical Outcome of Corticosteroids in the Treatment of COPD Exacerbations in China
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in China.
Trial summary
This is a Post-hoc analysis based on the database of "A non-interventional, retrospective study on AECOPD treatment status in China". A large nation-wide retrospective non-interventional study has carried out from January to September 2014 in China. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- How many people
- 5,067 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2017to 28 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with COPD exacerbations received hospitalization since September 2013
Who may be able to join
- Inpatients with COPD exacerbations who received Nebulized Budesonide(Neb. BUD), Systemic corticosteroids(SCS) and Neb. BUD combined with SCS treatment in 5067 cases of database were included.
Who cannot join
- The proportion of missing data for a variable at a specific site is too high to be concerned as highly variable or uncertain, then the data for this site will be excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Corticosteroids in the Treatment of Chronic Obstructive Pulmonary Disease(COPD) Exacerbations in China (CONTAIN Study): Post-hoc Analysis of the Database of Acute Exacerbation of COPD Non-interventional Study
This is a Post-hoc analysis based on the database of "A non-interventional, retrospective study on AECOPD treatment status in China". A large nation-wide retrospective non-interventional study has carried out from January to September 2014 in China. The study aimed to observe clinical practice including glucocorticoids treatment in AECOPD in China. The data for 5067 cases were collected. These cases met the following inclusion criteria: more than 40 years old, diagnosed by GOLD 2013 (GOLD: The Global Initiative for Chronic Obstructive Lung Disease) as COPD at least 3 months before AECOPD based on treating physician's judgment; the patients received hospitalization due to AECOPD since Sep 2013. Demographic information, administration of corticosteroids, medical and surgical history, comorbidities, clinical outcome, laboratory tests and lung function tests were recorded in database. There were 43 sites in the main study. These sites located in 22 provinces in China. A majority of sites (40 sites) were tier 3 hospitals in major cities. The data in study was provided by each site via medical records. In 5091 screening cases, 5067 cases were recruited and included in full analysis set (FAS). All cases in FAS will be included into this post-hoc analysis.
Through data mining and analysis, it is to explore the relationship between corticosteroids based treatment regimen and clinical outcome and the optimal treatment regimen for corticosteroids used in inpatients with COPD exacerbations based on our database.
Read the detailed description
In general, the statistical analyses based on raw data and the data using propensity score matching (PSM) will be primarily descriptive in nature. The statistics are as in the following:
- Continuous variables: N, mean, standard deviation, lower quartile Q1, median, upper quartile Q3, minimum, maximum;
- Categorical variables: frequencies and percentages of patients at each category.
Before the statistical analyses, the medical history and co-morbidities need to be coded using ICD10. At the same time, the data collected should be clearly understood and provide the following information but not limited to the number of subjects enrolled in each site, the list of variables, the number of observations of each variable and the missing proportion of the variable.
The factors involved into the logistic model for propensity score matching include but not limited to demographic, baseline characteristics, severity of COPD, etc. A factor research will be performed before the matching is performed aiming to include appropriate factors into the model. Matching ratio could be exact or approximate.
Programming software is SAS 9.3 (SAS: Statistical Analysis System) or higher in Windows system. R statistical software could be another tool for the exploration.
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospital stay(days)
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The rate of mortality
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide(BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The change of FEV1(Forced Expiratory Volume in the first second) after treatment
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
Secondary outcomes (7)
The rate of new-onset pneumonia during hospitalization
Evaluate the rate of new-onset pneumonia during hospitalization among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The cost during hospitalization
Evaluate the hospitalization cost among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The age
Evaluate demographic characteristics among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The sex
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The weight
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The height
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
Measured: day 1 to up to 30 days (Hospital discharge)
The COPD history
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised BUD, 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
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 posted16 Aug 2018
- Study start28 Feb 2017
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinfu XU, Prof., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633838
- Sponsor's protocol ID
- D589BR00037
- Acronym
- CONTAIN
- Status last verified
- Sep 2018
- First submitted
- 10 May 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Corticosteroids in the Treatment of Chronic Obstructive Pulmonary Disease(COPD) Exacerbations in China (CONTAIN Study): Post-hoc Analysis of the Database of Acute Exacerbation of COPD Non-interventional Study
- ClinicalTrials.gov ID
- NCT03633838
- Acronym / sponsor ID
- CONTAIN / D589BR00037
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,067 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 16 Aug 2018 (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.
This is a Post-hoc analysis based on the database of "A non-interventional, retrospective study on AECOPD treatment status in China". A large nation-wide retrospective non-interventional study has carried out from January to September 2014 in China. The study aimed to observe clinical practice including glucocorticoids treatment in AECOPD in China. The data for 5067 cases were collected. These cases met the following inclusion criteria: more than 40 years old, diagnosed by GOLD 2013 (GOLD: The Global Initiative for Chronic Obstructive Lung Disease) as COPD at least 3 months before AECOPD based on treating physician's judgment; the patients received hospitalization due to AECOPD since Sep 2013. Demographic information, administration of corticosteroids, medical and surgical history, comorbidities, clinical outcome, laboratory tests and lung function tests were recorded in database. There were 43 sites in the main study. These sites located in 22 provinces in China. A majority of sites (40 sites) were tier 3 hospitals in major cities. The data in study was provided by each site via medical records. In 5091 screening cases, 5067 cases were recruited and included in full analysis set (FAS). All cases in FAS will be included into this post-hoc analysis.
Through data mining and analysis, it is to explore the relationship between corticosteroids based treatment regimen and clinical outcome and the optimal treatment regimen for corticosteroids used in inpatients with COPD exacerbations based on our database.
Detailed description
In general, the statistical analyses based on raw data and the data using propensity score matching (PSM) will be primarily descriptive in nature. The statistics are as in the following:
- Continuous variables: N, mean, standard deviation, lower quartile Q1, median, upper quartile Q3, minimum, maximum;
- Categorical variables: frequencies and percentages of patients at each category.
Before the statistical analyses, the medical history and co-morbidities need to be coded using ICD10. At the same time, the data collected should be clearly understood and provide the following information but not limited to the number of subjects enrolled in each site, the list of variables, the number of observations of each variable and the missing proportion of the variable.
The factors involved into the logistic model for propensity score matching include but not limited to demographic, baseline characteristics, severity of COPD, etc. A factor research will be performed before the matching is performed aiming to include appropriate factors into the model. Matching ratio could be exact or approximate.
Programming software is SAS 9.3 (SAS: Statistical Analysis System) or higher in Windows system. R statistical software could be another tool for the exploration.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with COPD exacerbations received hospitalization since September 2013
Key inclusion criteria (1 listed)
- Inpatients with COPD exacerbations who received Nebulized Budesonide(Neb. BUD), Systemic corticosteroids(SCS) and Neb. BUD combined with SCS treatment in 5067 cases of database were included.
Key exclusion criteria (1 listed)
- The proportion of missing data for a variable at a specific site is too high to be concerned as highly variable or uncertain, then the data for this site will be excluded from the analysis.
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
The length of hospital stay(days)
Time frame: day 1 to up to 30 days (Hospital discharge)
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
The rate of mortality
Time frame: day 1 to up to 30 days (Hospital discharge)
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide(BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
The change of FEV1(Forced Expiratory Volume in the first second) after treatment
Time frame: day 1 to up to 30 days (Hospital discharge)
Evaluate the clinical outcome among 3 treatment groups (1=Nebulised Budesonide (BUD), 2=Nebulised BUD+ Systemic corticosteroids (SCS), 3=SCS)
7 secondary outcomes
The rate of new-onset pneumonia during hospitalization
Time frame: day 1 to up to 30 days (Hospital discharge)
The cost during hospitalization
Time frame: day 1 to up to 30 days (Hospital discharge)
The age
Time frame: day 1 to up to 30 days (Hospital discharge)
The sex
Time frame: day 1 to up to 30 days (Hospital discharge)
The weight
Time frame: day 1 to up to 30 days (Hospital discharge)
The height
Time frame: day 1 to up to 30 days (Hospital discharge)
The COPD history
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 14 Sep 2018.
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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.
Jinfu XU, Prof. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site 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 1 site 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 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: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The length of hospital stay(days) (time frame: day 1 to up to 30 days (Hospital discharge)). The study lists 3 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 14 Sep 2018.