UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027281 |
|---|---|
| Receipt number | R000031247 |
| Scientific Title | Evaluation of pharmacist intervention for inhalation therapy in patients with chronic obstructive pulmonary disease (COPD) and asthma. |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2019/05/13 09:48:27 |
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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
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
sato-hito@pharm.showa-u.ac.jp
Public contact
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
nakanobu-p@ip-members.net
Sponsor or person
Institute
School of pharmacy, Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031247
