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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013541
Receipt No. R000015821
Scientific Title Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Date of disclosure of the study information 2014/03/27
Last modified on 2018/10/04

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Basic information
Public title Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Acronym Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Scientific Title Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Scientific Title:Acronym Correlational analysis between respiratory mechanics measured by forced oscillation technique and respiratory anatomical structure evaluated by 3-dimensional CT imaging in patients with obstructive lung diseases and diffuse pulmonary diseases.
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
bronchial asthma
sarcoidosis
interstitial lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate correlation between respiratory mechanics and anatomical structure of lungs in patients with chronic lung diseases.
Basic objectives2 Others
Basic objectives -Others correlation analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiratory resistance
respiratory reactance
luminal area of airway
wall thickness or airway
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were diagnosed with COPD, bronchial asthma, sarcoidosis, or interstitial lung disease.
Patients who gave written informed consent.
Key exclusion criteria Patients who could not underwent forced oscillation test or chest computed tomography.
Patients who did not give written informed consent.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu Univ. School of Medicine
Division name Second devision, department of internal medicine
Zip code
Address Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Karayama
Organization Hamamatsu Univ. School of Medicine
Division name Second devision, department of internal medicine
Zip code
Address Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL 053-435-2263
Homepage URL
Email karayama@hama-med.ac.jp

Sponsor
Institute Second devision, department of internal medicine, Hamamatsu Univ. School of Medicine
Institute
Department

Funding Source
Organization Second devision, department of internal medicine, Hamamatsu Univ. School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective random sampling

Management information
Registered date
2014 Year 03 Month 27 Day
Last modified on
2018 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015821

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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