UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013020
Receipt number R000014879
Scientific Title Research on obstructive lung disease
Date of disclosure of the study information 2014/04/01
Last modified on 2021/03/27 23:14:27

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Basic information

Public title

Research on obstructive lung disease

Acronym

Research on obstructive lung disease

Scientific Title

Research on obstructive lung disease

Scientific Title:Acronym

Research on obstructive lung disease

Region

Japan


Condition

Condition

smokers and non-smokers with asthma, COPD patients with atopy

Classification by specialty

Medicine in general Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study overlap syndrome comprehensively

Basic objectives2

Others

Basic objectives -Others

To investigate the pathophysiology of overlap syndrome

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To investigate factors that define FEV1/FVC

Key secondary outcomes

To investigate mechanisms underluing the defined phenotypes of overlap syndrome


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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with overlap syndrome of asthma and COPD

Key exclusion criteria

tuberculosis, pneunomia, interstitial pneumonia, lung cancer

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Hisako
Middle name
Last name Matsumoto

Organization

Graduate School of Medicien, Kyoto University

Division name

Respiratory Medicine

Zip code

606-8507

Address

54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan

TEL

+81-75-751-3830

Email

hmatsumo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Chie
Middle name
Last name Morimoto

Organization

Graduate School of Medicien, Kyoto University

Division name

Respiratory Medicine

Zip code

606-8507

Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan

TEL

+81-75-751-3830

Homepage URL


Email

cmorimo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Respiratory Medicine, Graduate School of Medicien, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Scholarship

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

+81-75-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

E2049

Org. issuing International ID_1

Ethics Committee of Kyoto University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 12 Month 20 Day

Date of IRB

2018 Year 08 Month 30 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To compare patients with overlap syndrome with never smokers with asthma or non-atopic COPD patients


Management information

Registered date

2014 Year 01 Month 30 Day

Last modified on

2021 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name