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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003193
Receipt No. R000003856
Scientific Title Development of non-invasive methods for diagnosis of asthma and chronic obstructive pulmonary disease (COPD) and for difference between asthma and COPD.
Date of disclosure of the study information 2010/03/01
Last modified on 2017/08/31

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Basic information
Public title Development of non-invasive methods for diagnosis of asthma and chronic obstructive pulmonary disease (COPD) and for difference between asthma and COPD.
Acronym Development of non-invasive method for difference between asthma and COPD.
Scientific Title Development of non-invasive methods for diagnosis of asthma and chronic obstructive pulmonary disease (COPD) and for difference between asthma and COPD.
Scientific Title:Acronym Development of non-invasive method for difference between asthma and COPD.
Region
Japan

Condition
Condition Asthma and chronic obstructive pulmonary disease (COPD).
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose in this study is to develop non-invasive methods independent on effort for difference between asthma and COPD using new technology such as forced oscillation technique, metronome-paced hyperventilation technique for evaluation of dynamic hyperinflation, measurement of exhaled nitric oxide, analysis of exhaled breath condensate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Decreases in respiratory impedance and dynamic hyperinflation and increases in exhaled nitric oxide 30 minute after the inhalation of a short-acting bronchodilator.
Key secondary outcomes Analysis of proteins and peptides in exhaled breath condensate obtained before the inhalation of a short-acting bronchodilator.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Inhalation of procaterol hydrochloride 20 microgram.
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
15 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy never-smokers without any presence and histories of chronic respiratory and allergic diseases, and patients with asthma and chronic obstructive pulmonary disease (COPD) recruited from out-patient clinic of Shinshu University Hospital.
Key exclusion criteria Healthy subjects who have smoking history or have histories of asthma or chronic respiratory diseases are excluded. Asthyma patients who have smoking history or severe cardiovascular diseases are excluded. COPD patients complicated with asthma or who have histories of asthma or severe cardiovascular diseases are excluded.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisaku Fujimoto
Organization Shinshu University School of Medicine
Division name Department of Biomedical Laboratory Sciences, Health Sciences.
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2393
Email keisaku@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisaku Fujimoto
Organization Shinshu University School of Medicine
Division name Department of Biomedical Laboratory Sciences, Health Sciences.
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2393
Homepage URL
Email keisaku@shinshu-u.ac.jp

Sponsor
Institute Department of Biomedical Laboratory Sciences, Shinshu University School of Health Sciences.
Institute
Department

Funding Source
Organization Hokuto Foundation for Bioscience
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 信州大学医学部付属病院(長野県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 16 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003856

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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