UMIN-CTR Clinical Trial

Public title

A prospective cohort study of asthma and COPD overlap in Japanese patients with COPD according to the diagnostic criteria of The Japanese Respiratory Society

Acronym

ACO Registry

Scientific Title

A prospective cohort study of asthma and COPD overlap in Japanese patients with COPD according to the diagnostic criteria of The Japanese Respiratory Society

Scientific Title:Acronym

ACO Registry

Region

Japan

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tatsunori Jinnai

Organization

AstraZeneca.KK.

Division name

Medical

Zip code

Address

3-1, Ofuna-cho, Kita-ku, Osaka

TEL

06-7711-3714

Email

Tatsunori.Jinnai@astrazeneca.com

Name of contact person

1st name
Middle name
Last name	Tatsunori Jinnai

Organization

AstraZeneca.KK.

Division name

Medical

Zip code

Address

3-1, Ofuna-cho, Kita-ku, Osaka

TEL

06-7711-3714

Homepage URL

Email

Tatsunori.Jinnai@astrazeneca.com

Institute

AstraZeneca.KK.

Institute

Department

Personal name

Organization

AstraZeneca.KK.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

04

Month

25

Day

Date of IRB

2018

Year

05

Month

23

Day

Anticipated trial start date

2018

Year

06

Month

13

Day

Last follow-up date

2021

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

multicenter, Prospective, cohort registry

Secondary use of the data of this study in other study called "Real-World Treatment Patterns and Patient reported outcome in COPD (REMIND)
A secondary database study using COPD cohort study in Japan to investigate health status of COPD patients with different inhaler treatment" (jRCT1030230176).

Registered date

2018

Year

06

Month

06

Day

Last modified on

2023

Year

06

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037501