COPDNCT02413359
High Risk Populations Among COPD Patients in Japan
An observational study of COPD, run by AstraZeneca at 1 site in Japan.
Trial summary
The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 150 years
- Conditions the study is for
- COPD
- How many people
- 1,016 participants
- Where
- 1 siteJapan
- Study dates
- May 2015to Jul 2015
- 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 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of COPD
Who may be able to join
- Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records)
- Patients aged 40 years and over at the diagnosis of COPD
- Outpatient
- 10 or more pack-years of current or former smokers
- Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year
- Patients who meet any of the following two criteria
Show all 9Show fewer
- Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years
- Patients who can provide the results of reversibility testing for respiratory tract
- Patients who give written informed consent regarding the participation in this study
Who cannot join
- Patients currently with COPD exacerbations
- Patients who currently enroll in the other interventional study including clinical trials
- Patients who concurrently develop or have a history of lung cancer
- Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Study in Patients With COPD in High Risk Population in Japan: Proportion of Overlap Between COPD and Asthma, and the Relationship With COPD Exacerbation
The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.
Read the detailed description
Study Site(s), number of subjects planned Number of study sites planned for this research study (scheduled) 60 (undetermined) Number of subjects planned for this research study (scheduled) 1,100 patients
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ACOS defined by The Global Initiative for Asthma (GINA) and The Global Initiative for Chronic Obstructive Lung Disease (GOLD) in patients with COPD receiving outpatient treatment and follow-up by physicians in Japan.
Measured: up to 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atsuhi Yoshida, AstraZeneca, Study director, Japan - Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413359
- Sponsor's protocol ID
- D589BR00033
- Status last verified
- Sep 2016
- First submitted
- 7 Apr 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Study in Patients With COPD in High Risk Population in Japan: Proportion of Overlap Between COPD and Asthma, and the Relationship With COPD Exacerbation
- ClinicalTrials.gov ID
- NCT02413359
- Acronym / sponsor ID
- D589BR00033
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Apr 2015 (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 patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.
Detailed description
Study Site(s), number of subjects planned Number of study sites planned for this research study (scheduled) 60 (undetermined) Number of subjects planned for this research study (scheduled) 1,100 patients
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of COPD
Key inclusion criteria (9 listed)
- Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records)
- Patients aged 40 years and over at the diagnosis of COPD
- Outpatient
- 10 or more pack-years of current or former smokers
- Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year
Key exclusion criteria (4 listed)
- Patients currently with COPD exacerbations
- Patients who currently enroll in the other interventional study including clinical trials
- Patients who concurrently develop or have a history of lung cancer
- Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)
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
Proportion of ACOS defined by The Global Initiative for Asthma (GINA) and The Global Initiative for Chronic Obstructive Lung Disease (GOLD) in patients with COPD receiving outpatient treatment and follow-up by physicians in Japan.
Time frame: up to 2 month
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 21 Sep 2016.
- CSR SynopsisLink provided by the sponsor.
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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.
Atsuhi Yoshida, AstraZeneca study director
Japan - Medical Affairs
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 COPD, run by AstraZeneca at 1 site in Japan.
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 9 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 21 Sep 2016. 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 Japan. 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?
Proportion of ACOS defined by The Global Initiative for Asthma (GINA) and The Global Initiative for Chronic Obstructive Lung Disease (GOLD) in patients with COPD receiving outpatient treatment and follow-up by physicians in Japan. (time frame: up to 2 month). 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 21 Sep 2016.