Pulmonary Disease, Chronic ObstructiveACO-RegistryNCT03577795
A Prospective Cohort Study of Asthma and COPD Overlap in Japanese COPD Patients Using the Diagnostic Criteria of The Japanese Respiratory Society
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in Japan.
Trial summary
This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 710 participants
- Where
- 1 siteJapan
- Study dates
- 19 Jun 2018to 19 Feb 2021
- How long will I take part?
- 2 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients should be 40 years old or older who satisfy the characteristics of COPD from The Japanese Respiratory Society's ACO diagnostic criteria within the past years or on the registration as well as who can regularly visit their study center in Japan.
Who may be able to join
- Patients from whom written consent to participate in this study has been obtained
- Patients ≥40 years old
- Patients with FEV1/FVC ratio <70% after bronchodilator inhalation within the past year or on the registrationa
- Patients who satisfy any one of the following items:
- 1) Smoking history (≥10 pack-years) or comparable air pollution exposure on the registrationa 2) Presence of the low attenuation area on chest CT demonstrating emphysematous alteration within the past year or on the registration a,b, 3) Impaired pulmonary diffusing capacity (%DLCO <80% or %DLCO/VA <80%) within the past year or on the registrationa 4) Patients deemed capable of visiting their study center in Japan at least once a year on an outpatient basis
Who cannot join
- Patients who participated in other interventional studies such as clinical trial within the last 8 weeks.
- Patients who are unsuitable for their enrollment in this study, judged by the participating physician, because they cannot comply with the procedures, restrictions, and requirements of this study (e.g., patients with dementia).
- Patients with exacerbationsa of COPD or asthma within the last 8 weeks. a COPD exacerbation: State of increased shortness of breathing, increased cough and sputum, and occurrence or exacerbation of chest discomfort that requires a change of treatment during the stable phase. However, exacerbation preceded by other disorders (e.g., heart failure, pneumothorax, pulmonary thromboembolism) is excluded.
- Asthma exacerbation: Occurrence of paroxysmal/variable cough/sputum/wheezing/dyspnea caused by various factors including respiratory infection.
- Patients carrying following disorders that should be distinguished from COPD or asthma:
- Diffuse panbronchiolitis, congenital sinobronchial syndrome, occlusive panbronchiolitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangioleiomyomatosis, congestive heart failure, interstitial lung disease, lung cancer, laryngitis, epiglottitis, vocal cord dysfunction, intratracheal tumor, airway foreign substance, tracheomalacia, bronchial tuberculosis, pulmonary thromboembolism, cough induced by drug such as angiotensin-converting enzyme inhibitor, spontaneous pneumothorax, hyperventilation syndrome, psychogenic cough
Trial locations and contacts
1 site in 1 country.
About this study
This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria.
Read the detailed description
This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria. The physicians will collect data including the patients' results from medical examinations by using the ACO diagnostic criteria, at each time point (on the registration, after 1 year, and after 2 years). Electronic case report forms completed by participating physicians and questionnaires completed by patients will be used to collect data.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, ACO, RWE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalance of ACO
- Proportion of patients diagnosed with ACO at least once at the time of registration, 1 year later, and 2 years later among all registered patients
- The number and proportion of ACO patients and non-ACO patients at the time of registration among patients who have data required for the diagnosis of ACO at the time of registration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start19 Jun 2018
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 710 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Masakazu Ichinose, Professor, Study chair, Tohoku University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577795
- Sponsor's protocol ID
- D5980R00005
- Acronym
- ACO-Registry
- Status last verified
- Jan 2022
- First submitted
- 23 May 2018
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashimoto S, Sorimachi R, Makita N, Tashiro N, Sugaya S, Arita Y, Ichinose M. Real-World Status of Medical Care and Treatment of Chronic Obstructive Pulmonary Disease by Respiratory Specialists in Japan. Adv Ther. 2022 Oct;39(10):4509-4521. doi: 10.1007/s12325-022-02167-5. Epub 2022 Jun 29.
PubMed 35767123Hashimoto S, Sorimachi R, Jinnai T, Ichinose M. Asthma and Chronic Obstructive Pulmonary Disease Overlap According to the Japanese Respiratory Society Diagnostic Criteria: The Prospective, Observational ACO Japan Cohort Study. Adv Ther. 2021 Feb;38(2):1168-1184. doi: 10.1007/s12325-020-01573-x. Epub 2020 Dec 23.
PubMed 33355907
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Asthma and COPD Overlap in Japanese COPD Patients Using the Diagnostic Criteria of The Japanese Respiratory Society
- ClinicalTrials.gov ID
- NCT03577795
- Acronym / sponsor ID
- ACO-Registry / D5980R00005
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, ACO, RWE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Linical Co., Ltd.
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 5 Jul 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 study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria.
Detailed description
This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria. The physicians will collect data including the patients' results from medical examinations by using the ACO diagnostic criteria, at each time point (on the registration, after 1 year, and after 2 years). Electronic case report forms completed by participating physicians and questionnaires completed by patients will be used to collect data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients should be 40 years old or older who satisfy the characteristics of COPD from The Japanese Respiratory Society's ACO diagnostic criteria within the past years or on the registration as well as who can regularly visit their study center in Japan.
Key inclusion criteria (5 listed)
- Patients from whom written consent to participate in this study has been obtained
- Patients ≥40 years old
- Patients with FEV1/FVC ratio <70% after bronchodilator inhalation within the past year or on the registrationa
- Patients who satisfy any one of the following items:
- 1) Smoking history (≥10 pack-years) or comparable air pollution exposure on the registrationa 2) Presence of the low attenuation area on chest CT demonstrating emphysematous alteration within the past year or on the registration a,b, 3) Impaired pulmonary diffusing capacity (%DLCO <80% or %DLCO/VA <80%) within the past year or on the registrationa 4) Patients deemed capable of visiting their study center in Japan at least once a year on an outpatient basis
Key exclusion criteria (6 listed)
- Patients who participated in other interventional studies such as clinical trial within the last 8 weeks.
- Patients who are unsuitable for their enrollment in this study, judged by the participating physician, because they cannot comply with the procedures, restrictions, and requirements of this study (e.g., patients with dementia).
- Patients with exacerbationsa of COPD or asthma within the last 8 weeks. a COPD exacerbation: State of increased shortness of breathing, increased cough and sputum, and occurrence or exacerbation of chest discomfort that requires a change of treatment during the stable phase. However, exacerbation preceded by other disorders (e.g., heart failure, pneumothorax, pulmonary thromboembolism) is excluded.
- Asthma exacerbation: Occurrence of paroxysmal/variable cough/sputum/wheezing/dyspnea caused by various factors including respiratory infection.
- Patients carrying following disorders that should be distinguished from COPD or asthma:
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
Prevalance of ACO
Time frame: 2 years
1. Proportion of patients diagnosed with ACO at least once at the time of registration, 1 year later, and 2 years later among all registered patients 2. The number and proportion of ACO patients and non-ACO patients at the time of registration among patients who have data required for the diagnosis of ACO at the time of registration
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 10 Feb 2022.
- Derived from this study: PubMed 35767123Hashimoto S, Sorimachi R, Makita N, Tashiro N, Sugaya S, Arita Y, Ichinose M. Real-World Status of Medical Care and Treatment of Chronic Obstructive Pulmonary Disease by Respiratory Specialists in Japan. Adv Ther. 2022 Oct;39(10):4509-4521. doi: 10.1007/s12325-022-02167-5. Epub 2022 Jun 29.
- Derived from this study: PubMed 33355907Hashimoto S, Sorimachi R, Jinnai T, Ichinose M. Asthma and Chronic Obstructive Pulmonary Disease Overlap According to the Japanese Respiratory Society Diagnostic Criteria: The Prospective, Observational ACO Japan Cohort Study. Adv Ther. 2021 Feb;38(2):1168-1184. doi: 10.1007/s12325-020-01573-x. Epub 2020 Dec 23.
- 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.
Masakazu Ichinose, Professor study chair
Tohoku University School of Medicine
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 Pulmonary Disease, Chronic Obstructive, 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 5 inclusion and 6 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 10 Feb 2022. 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?
Prevalance of ACO (time frame: 2 years). 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 NCT03577795, which also lists 2 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 10 Feb 2022.