UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003193 |
|---|---|
| Receipt number | 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 15:33:04 |
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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
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
keisaku@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Biomedical Laboratory Sciences, Shinshu University School of Health Sciences.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003856
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
