UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of pharmacist intervention for inhalation therapy in patients with chronic obstructive pulmonary disease (COPD) and asthma.
Acronym	Evaluation of pharmacist intervention for inhalation therapy
Scientific Title	Evaluation of pharmacist intervention for inhalation therapy in patients with chronic obstructive pulmonary disease (COPD) and asthma.
Scientific Title:Acronym	Evaluation of pharmacist intervention for inhalation therapy
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease (COPD), asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is evaluation of pharmacist intervention for inhalation therapy by assessment and education of inhalation technique in patients with chronic obstructive pulmonary disease (COPD) and asthma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	inhalation technique
Key secondary outcomes	SpO2, peak flow rate, subjective symptoms, adherence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	questionnaire about inhalation therapy, assessment and education of inhalation technique (every visit to a trial phamacy, 4-8 times for four months)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	COPD or asthma outpatients treated with inhalation therapy for more than three months
Key exclusion criteria	Patients are excluded if they have cancer, sever liver or renal dysfunction, and difficulty of inhaling by themselves.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hitoshi Sato
Organization	School of pharmacy, Showa University
Division name	Division of Pharmacokinetics and Pharmacodynamics, Department of Drug Information
Zip code
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8612
Email	sato-hito@pharm.showa-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Eisaku Tomioka
Organization	Nakanobu Dispensing Pharmacy
Division name	Pharmacy
Zip code
Address	2-5-5 Nishinakanobu, Shinagawa-ku, Tokyo, Japan
TEL	03-5749-3507
Homepage URL
Email	nakanobu-p@ip-members.net

Sponsor
Institute	School of pharmacy, Showa University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nakanobu Depending Pharmacy
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	中延調剤薬局 Nakanobu Dispensing Pharmacy 小山調剤薬局 Koyama Dispensing Pharmacy 糀谷調剤薬局 Kojiya Dispensing Pharmacy

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 10 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	2017 Year 04 Month 05 Day
Date of IRB	2017 Year 04 Month 05 Day
Anticipated trial start date	2017 Year 04 Month 05 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 09 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031247