UMIN-CTR Clinical Trial

Basic information
Public title	Improvement by the fact of the inhalational style in the inhaler of the patients with obstructive lung disease and the inhalational instruction
Acronym	Improvement by a fact and the instruction of the inhalation of the obstructive lung disease therapeutic drug
Scientific Title	Analysis and Instruction of inhaling flow patter through Turbuhaler or Discus in the patients with obstructive lung diseases
Scientific Title:Acronym	Improvement of the actual situation of the inhalational style from Turbuhaler (TBH) or discus (DKS) and the inhalational instruction
Region	Japan

Condition
Condition	obstructive lung diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An inhalational therapeutic drug of the asthma bronchial includes a discus in Turbuhaler, but we make patients with each inhale it and measure real inhalation pattern and drug burst size and prove that we teach inhalation if inappropriate inhalation is performed, and improvement is obtained.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We measure the maximal inspiration speed and drug burst size of 2-4 weeks.
Key secondary outcomes

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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Person age 18 years old or older The patients with asthma bronchial to COPD (each definition follows guidelines on GOLD which is international criteria and GNA) The person who obtained written consent by the free will of the person in response to enough explanation on participating to one of this study The inhalation that is inappropriate in initial evaluation and the person who was judged
Key exclusion criteria	The person whom adherence of the inhalation has bad (inhalant rate of use less than 70%) Patients with severe COPD (anti-predicted value forced expiratory volume one second percent less than 49%) The person who is complicated with heart failure, neuromuscular disorders of the patients altitude with chronic respiratory tract infection
Target sample size	35

Research contact person
Name of lead principal investigator	1st name SAKURAKO Middle name Last name TAJIRI
Organization	Tokai University Oiso Hospita
Division name	Respiratory Medicine
Zip code	2591141
Address	21-1
TEL	0463723211
Email	sakurako@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name SAKURAKO Middle name Last name TAJIRI
Organization	Tokai University Oiso Hospital
Division name	Respiratory Medicine
Zip code	2591141
Address	Gakkyo, Oiso-machi, Naka-gun, Kanagawa 21-1
TEL	0463723211
Homepage URL
Email	sakurako@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	No
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	Tokai University Ethical Review Board
Address	143, Shimokasuya, Isehara-shi, Kanagawa
Tel	0463931121
Email	sakurako@is.icc.u-tokai.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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 18 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	Completed
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 03 Month 14 Day
Last follow-up date	2022 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	When improvement of inhalational speed and the drug burst size is obtained by inhalational instruction, we expect it

Management information
Registered date	2021 Year 08 Month 18 Day
Last modified on	2022 Year 08 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051628