UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013020
Receipt No. R000014879
Scientific Title Research on obstructive lung disease
Date of disclosure of the study information 2014/04/01
Last modified on 2021/03/27

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

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
URL(English) 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


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