UMIN-CTR Clinical Trial

Basic information
Public title	Optimal inhalation profiles from dry powder inhalers
Acronym	Optimal inhalation profiles from DPI
Scientific Title	Optimal inhalation profiles from dry powder inhalers
Scientific Title:Acronym	Optimal inhalation profiles from DPI
Region	Japan

Condition
Condition	bronchial asthma chronic obstructive pulmonary disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine optimal flow patterns from different dry powder inhalers for drug releases.
Basic objectives2	Others
Basic objectives -Others	To investigate whether the patients using dry powder inhalers inhale with optimal flow patterns.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of drug release from the dry powder inhaler in response to different inhaled flow patterns (in vitro study)
Key secondary outcomes	Similarity of patients' inhaled flow patterns from dry powder inhalers to those from in vitro studies (in vivo study)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with bronchial asthma or chronic obstructive pulmonary disease who regularly visit respiratory medicine department of Shonan Fujisawa Tokushukai Hospital, and voluntarily agreed to the study after hearing precise explanation of the study.
Key exclusion criteria	Those who fell into acute exacerbation at the time of study.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Tetsuri Middle name Last name Kondo
Organization	Shonan Fujisawa Tokushukai Hospital
Division name	Respiratory Medicie
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	Department of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 11 Month 02 Day

Related information
URL releasing protocol	https://www.resmedjournal.com/article/S0954-6111(22)00215-3/fulltext
Publication of results	Published

Result
URL related to results and publications	https://www.resmedjournal.com/article/S0954-6111(22)00215-3/fulltext
Number of participants that the trial has enrolled	1
Results	Seven asthmatics without recent deterioration and regularly inhaling Turbuhaler or Diskus. Daily inhalation profiles and particle release from either DPI were measured at home for 2 weeks. Inhalation flow profile measured at home is highly reproducible, but tends to be weaker and shorter than that measured in the laboratory. Particle release from Turbuhaler was peak flow-dependent, but that from Diskus was not. The results confirm that rapid inhalations from the start are required when using a DPI.
Results date posted	2022 Year 10 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 09 Month 01 Day
Baseline Characteristics	One asthmatic patient who was regularly visit Shonan Fujisawa Tokushukai Hospital without recent deterioration and regularly inhaling Turbuhaler.
Participant flow	Masked clinical data was provided to the research group.
Adverse events	none
Outcome measures	Daily inhalation profiles and particle release from Turbuhaler, peak inspiratory flow, inhaled volume
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 07 Day
Date of IRB	2016 Year 01 Month 30 Day
Anticipated trial start date	2016 Year 02 Month 05 Day
Last follow-up date	2021 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In both simulation and clinical studies, inhaled flow rate and dispersed drug from dry powder inhaler are recorded. In simulation study, several inhalation patterns are applied. In clinical study subjects inhale from dry powder inhaler as he or her usual way.

Management information
Registered date	2016 Year 10 Month 29 Day
Last modified on	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028132