UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020725 |
|---|---|
| Receipt number | R000019275 |
| Scientific Title | A study to obtain an index which objectively evaluate decreased adherence to inhaled corticosteroid in asthma |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2019/02/07 23:01:42 |
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Basic information
Public title
A study to obtain an index which objectively evaluate decreased adherence to inhaled corticosteroid in asthma
Acronym
an index for decreased adherence to inhaled corticosteroid
Scientific Title
A study to obtain an index which objectively evaluate decreased adherence to inhaled corticosteroid in asthma
Scientific Title:Acronym
an index for decreased adherence to inhaled corticosteroid
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this study was to elucidate whether the rate of change of fractional expired nitric oxide concentration are biomarker for decreased adherence to inhaled corticosteroid in asthma.
Basic objectives2
Others
Basic objectives -Others
Biomarker Discovery
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of the rate of change of fractional expired nitric oxide concentration and inhaled corticosteroid use frequency
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
Subject is diagnosed with asthma according to the Japanese Asthma Prevention and Management Guidelines (JGL). Subject has signed the informed concent form.
Key exclusion criteria
Exclusion criteria included COPD, interstitial pneumonia, infectious disease, and active cancer.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Harada |
Organization
Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL
03-5802-1063
nor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Harada |
Organization
Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
3-1-3 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL
03-5802-1063
Homepage URL
nor@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2016 | Year | 01 | Month | 25 | 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 | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was to elucidate whether the rate of change of fractional expired nitric oxide concentration are biomarker for decreased adherence to inhaled corticosteroid in asthma.
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019275
