UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023136 |
|---|---|
| Receipt number | R000025990 |
| Scientific Title | Visualization of inhaled flow in achieving optimal use of a dry powder inhaler |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2022/10/31 18:15:08 |
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Basic information
Public title
Visualization of inhaled flow in achieving optimal use of a dry powder inhaler
Acronym
Inhaled flow from dry powder inhaler
Scientific Title
Visualization of inhaled flow in achieving optimal use of a dry powder inhaler
Scientific Title:Acronym
Inhaled flow from dry powder inhaler
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To solve the questions whether DPI (dry powder inhaler) instructors themselves inhale from a DPI with appropriate flow pattern, and if not, whether self-training with visual feedback is effective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of the DPI instructors who inhale from DPI with appropriate flow pattern.
Key secondary outcomes
Number of the DPI instructors who have achieved appropriate inhalation pattern after self-training using a new visual feedback device.
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
visualization of inhaling flow pattern from the DPI
using this device, self training for optimal inhalation approximately for one day
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pharmacists who are working in Shonan Fujisawa Tokushiukai Hospital and routinely do instruction of the DPI use.
Key exclusion criteria
Those who do not voluntarily agree to be participated in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL
0466-35-1177
tetsuri@ctmc.jp
Public contact
Name of contact person
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL
0466-35-1177
Homepage URL
tetsuri@ctmc.jp
Sponsor or person
Institute
Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital
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
Shonan Fujisawa Tokushukai Hospital
Address
1-5-1 Kandai Tsujido, Fujisawa, Kanagawa
Tel
0463592825
tetsuri@ctmc.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
http://creativecommons.org/publicdomain/zero/1.0/
Publication of results
Published
Result
URL related to results and publications
http://creativecommons.org/publicdomain/zero/1.0/
Number of participants that the trial has enrolled
14
Results
Background: An optimal inhalation flow pattern is essential for effective use of a dry powder inhaler (DPI). We wondered whether DPI instructors inhale from a DPI with an appropriate pattern, and if not, whether self-training with visual feedback is effective.
Results date posted
| 2022 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
pharmacists regularly engaged in instruction in dry powder inhaler use
Participant flow
After obtaining informed consent, subjects inhaled from the Diskus or Trubuhaler. Inhalation parameters were obtained from these inhalation maneuvers.
Adverse events
none
Outcome measures
Peak inhalation flow rate (PIFR), time reaching PIFR, inhalation volume, and flow at 0.3 s after the onset of inhalation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025990
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