UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033527 |
|---|---|
| Receipt number | R000038227 |
| Scientific Title | Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD |
| Date of disclosure of the study information | 2018/07/27 |
| Last modified on | 2024/01/29 16:06:28 |
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Basic information
Public title
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD
Acronym
Inhaler use technique and satisfaction with inhaler devices in COPD patients
Scientific Title
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD
Scientific Title:Acronym
Inhaler use technique and satisfaction with inhaler devices in COPD patients
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with inhaler devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Education of inhaler use technique, once
Interventions/Control_2
No education
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. forced expiratory volume% in 1 second under 70%
2. Age over 40
3. Use of inhaler devices (respimat, breezehaler or elipta) for over 3 months
4. Patients with consents informed
Key exclusion criteria
1. Patients with bronchial asthma or other respiratory diseases
2. Patients who can not get an understanding of inhalation technique guidance
3. Patients judged inappropriate as subjects by the principal investigator
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Hospital
Division name
Division of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
satotada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Kuwasaki |
Organization
Juntendo University Hospital
Division name
Division of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ekuwasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Juntendo University Hospital Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.ac.jp
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
順天堂大学附属順天堂医院（東京都）、順天堂大学医学部附属浦安病院（千葉県）、済生会川口総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
155
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038227
| 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 |
