UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010137 |
|---|---|
| Receipt number | R000011823 |
| Scientific Title | Use the inhaler device to study the effective levels of inhalation from new outpatients. |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2016/02/28 13:11:14 |
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Basic information
Public title
Use the inhaler device to study the effective levels of inhalation from new outpatients.
Acronym
Use the inhaler device to study the effective levels of inhalation from new outpatients.
Scientific Title
Use the inhaler device to study the effective levels of inhalation from new outpatients.
Scientific Title:Acronym
Use the inhaler device to study the effective levels of inhalation from new outpatients.
Region
| Japan |
Condition
Condition
Bronchial asthma
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effectiveness of the inhaler device tool as an inhalation therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effective level of inhalation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
with inhalation guidance combined with motion picture tool.
Interventions/Control_2
without inhalation guidance combined with motion picture tool.
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
1. Age is 20 years old or more.
2. Patients diagnosed with Asthma, or COPD and have been prescribed with inhaler.
3. got the consent/permission of the patients.
Key exclusion criteria
1. Patients with hypersensitivity to inahalation content.
2. Patients with chronic diseases, (Lung, Heart, Kidney, Liver, and Blood.)
3. Patient with adrenocortical disfunction.
4. Patients that wishes pregnancy.
5. Patients with inhalation technique is difficult.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Taguchi |
Organization
Mie University Graduate School of Medicine
Division name
Dept. of Pulmonary and Critical Care Medicine
Zip code
Address
2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL
059-232-1111
taguchio@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Kobayashi |
Organization
Mie University Graduate School of Medicine
Division name
Dept. of Pulmonary and Critical Care Medicine
Zip code
Address
2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL
059-232-1111
Homepage URL
ktetsu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate 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
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
| 2013 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
Management information
Registered date
| 2013 | Year | 02 | Month | 28 | Day |
Last modified on
| 2016 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011823
