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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023136
Receipt No. 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 2017/01/16

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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
Middle name
Last name Tetsuri Kondo
Organization Shonan Fujisawa Tokushukai Hospital
Division name Respiratory Medicine
Zip code
Address 1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL 0466-35-1177
Email tetsuri@ctmc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuri Kondo
Organization Shonan Fujisawa Tokushukai Hospital
Division name Respiratory Medicine
Zip code
Address 1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL 0466-35-1177
Homepage URL
Email tetsuri@ctmc.jp

Sponsor
Institute Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital
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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Methods: Subjects were 14 pharmacists regularly engaged in instruction in DPI use.  A newly designed handy inhalation flow visualizer (Visual Trainer: VT) was used to assess inhalation profiles and to assist in self-training. With a peak inhalation flow rate (PIFR) > 50 L/min, time reaching PIFR (TPF) < 0.4s, inhalation volume (VI) > 1L, and flow at 0.3 s after the onset of inhalation (F0.3) > 50 L/min, the pattern was considered optimal.
Results: Using Diskus or Turbuhaler 12 and 10 subjects respectively inhaled with a suitable PIFR. Those with a satisfactory F0.3 were 10 and 7 respectively. The TPF was short enough in only 1 and 2 respectively. All 14 subjects inhaled deeply (VI) through Diskus, and 10 did so through Turbuhaler. In the self-training session, only 3 subjects satisfied all three variables at the first trial, while 2 or 3 trials were required in other subjects. Among the three variables, optimal TPF was the most difficult to attain. Once a satisfactory inhalation pattern was achieved using one DPI, eleven out of 12 subjects inhaled with a satisfactory pattern through the other DPI.
Conclusion: Visualization of the inhalation flow pattern facilitates the learning of proper inhalation technique through a DPI.
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
2015 Year 02 Month 01 Day
Date of IRB
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
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025990

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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