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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033527
Receipt No. 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 2019/07/27

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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
Email 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
Email ekuwasa@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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

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
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 Open public 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
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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