UMIN-CTR Clinical Trial

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
Email	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
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	Shonan Fujisawa Tokushukai Hospital
Address	1-5-1 Kandai Tsujido, Fujisawa, Kanagawa
Tel	0463592825
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025990