UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019953 |
|---|---|
| Receipt number | R000023040 |
| Scientific Title | The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2017/05/10 19:46:37 |
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Basic information
Public title
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Acronym
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Scientific Title
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Scientific Title:Acronym
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Region
| Japan |
Condition
Condition
respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Basic objectives2
Others
Basic objectives -Others
The evaluation of airway and/or lung inflammation via a fraction of exhaled nitric oxide
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation between exhaled nitric oxide and several parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
mesurements of a fraction of exhaled nitric oxide
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
| 0 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy control and patients suffering from bronchial asthma, COPD, interstitial pneumonia, drug induced lung disease, lung cancer, radiation pneumonia, acute pneumonia, bronchiectasis and sarcoidosis.
Key exclusion criteria
patients with hemoptysis
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Hasegawa |
Organization
Nagoya University
Division name
respiratory medicine
Zip code
Address
65 tsurumai syowaku Nagoya
TEL
0527442167
yhasega@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Wakahara |
Organization
Nagoya University
Division name
respiratory medicine
Zip code
Address
65 tsurumai syowaku Nagoya
TEL
0527442167
Homepage URL
wakahara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
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
| 2015 | Year | 11 | Month | 27 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2017 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023040
