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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028913
Receipt No. R000033077
Scientific Title Evaluation of respiratory mechanics in patients with obstructive lung diseases
Date of disclosure of the study information 2017/08/30
Last modified on 2018/12/13

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Basic information
Public title Evaluation of respiratory mechanics in patients with obstructive lung diseases
Acronym Evaluation of respiratory mechanics in patients with obstructive lung diseases
Scientific Title Evaluation of respiratory mechanics in patients with obstructive lung diseases
Scientific Title:Acronym Evaluation of respiratory mechanics in patients with obstructive lung diseases
Region
Japan

Condition
Condition bronchial asthma
asthma-COPD overlap
COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze clinical features and airway structural changes in patients with obstructive lung diseases.
Basic objectives2 Others
Basic objectives -Others intergroup trial
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes patient characteristics
wall thickness of airway
luminal area of airway
pulmonary function tests
broadband forced oscillation technique
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were diagnosed with obstructive lung diseases.
Patients who gave written informed consent.
Key exclusion criteria Patients who could not underwent pulmonary
function test, forced oscillation test or chest computed tomography.
Patients who did not give written informed consent.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu university school of medicine
Division name The second division, 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 Mitsuru Niwa
Organization Hamamatsu university school of medicine
Division name The second division, department of internal medicine
Zip code
Address Handayama 1-20-1, Hamamatsu, Shizuoka pref.
TEL 053-435-2263
Homepage URL
Email mtr.nw@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization Hamamatsu university 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
2017 Year 08 Month 30 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
2015 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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 observational study

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033077

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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