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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032891
Receipt No. R000037501
Official scientific title of the study A prospective cohort study of asthma and COPD overlap in Japanese patients with COPD according to the diagnostic criteria of The Japanese Respiratory Society
Date of disclosure of the study information 2018/06/06
Last modified on 2018/06/06

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Basic information
Official scientific title of the study A prospective cohort study of asthma and COPD overlap in Japanese patients with COPD according to the diagnostic criteria of The Japanese Respiratory Society
Title of the study (Brief title) ACO Registry
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is a prospective investigation in clinical practice to investigate the proportion of patients with COPD who fulfill the criteria of ACO according to the diagnostic criteria of the Japanese Respiratory Society. In addition, as secondary objectives, patient demographics, clinical characteristics, and symptoms will be compared and examined between patients who are continuously diagnosed with COPD or ACO and patients who are variable in COPD or ACO diagnosis during the study period, and individual characteristics will be demonstrated.
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients fulfilling the diagnostic criteria for ACO at the time of registration, 1 year later, and 2 years later
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients from whom written consent to participate in this study has been obtained.
2)Patients >= 40 years old
3)Patients with the rate of forced expiratory volume in one second (FEV1/FVC) less than 70% after inhalation of a bronchodilator within the past year or at the time of registration
4)Patients who fulfill one of the following criteria:
[1]Smoking history (>=10 pack-years) or equivalent air pollution exposurea at the time of registration
[2]Presence of low absorption region showing emphysematous change on chest CTb,
[3]Lung diffusion impairment (%DLco <80%, DLco/VA <80%)
5)Outpatients assessed as being able to visit the study site at least once a year
Key exclusion criteria 1)Patients who participated in an intervention study such as a clinical trial within the last 8 weeks
2)Patients who is not appropriate for joining this study, judged by the investigators, due to the reasons such as they cannot comply with the procedures, restrictions and requirements of this study
3)Patients who experienced exacerbation of COPD or asthma within the last 8 weeks
4)Patients who have following diseases which cannot be distinguished from COPD or asthma at the time of obtaining consent:
Diffuse panoramic bronchitis, congenital sinus bronchial syndrome, obstructive panbronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangiomyomatosis, interstitial lung disease, lung cancer, vocal fold dysfunction, intratracheal tumor, tracheal softening, bronchial tuberculosis, pulmonary thromboembolism, congestive heart failure
Target sample size 700

Research contact person
Name of lead principal investigator Tatsunori Jinnai
Organization AstraZeneca.KK.
Division name Medical
Address 3-1, Ofuna-cho, Kita-ku, Osaka
TEL 06-7711-3714
Email Tatsunori.Jinnai@astrazeneca.com

Public contact
Name of contact person Tatsunori Jinnai
Organization AstraZeneca.KK.
Division name Medical
Address 3-1, Ofuna-cho, Kita-ku, Osaka
TEL 06-7711-3714
Homepage URL
Email Tatsunori.Jinnai@astrazeneca.com

Sponsor
Institute AstraZeneca.KK.
Institute
Department

Funding Source
Organization AstraZeneca.KK.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 25 Day
Anticipated trial start date
2018 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information multicenter, Prospective, cohort registry

Management information
Registered date
2018 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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