UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029730 |
|---|---|
| Receipt number | R000033893 |
| Scientific Title | Examination of the symptom by a pharmacist performing continuously inhalational instruction for the asthmatic patients who newly introduced Symbicort Tubuhaler. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/04/28 20:04:49 |
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Basic information
Public title
Examination of the symptom by a pharmacist performing continuously inhalational instruction for the asthmatic patients who newly introduced Symbicort Tubuhaler.
Acronym
Examination of the symptom by a pharmacist performing continuously inhalational instruction for the asthmatic patients who newly introduced Symbicort Tubuhaler.
Scientific Title
Examination of the symptom by a pharmacist performing continuously inhalational instruction for the asthmatic patients who newly introduced Symbicort Tubuhaler.
Scientific Title:Acronym
Examination of the symptom by a pharmacist performing continuously inhalational instruction for the asthmatic patients who newly introduced Symbicort Tubuhaler.
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We think about how much affects the symptom by continuing the inhalational instruction by the pharmacist.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Asthma Control Test (ACT) six months after initial instruction.
Key secondary outcomes
1.Technique of using inhalation device
2.Peak flow rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Continuously inhalational instruction by the pharmacist.
Four times of intervention (in the first time and the first month, the second month, the fourth month).
Interventions/Control_2
Only as for the initial inhalational instruction by the pharmacist.
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
The patient with asthma bronchial using Symbicort Turbuhaler for the first time.
Key exclusion criteria
1. The patients who remarkably have low understanding degree.
2. The patients with the sequelae that the movement of the finger is confined to remarkably.
3. In addition, the patients whom a study person in charge judged to be inadequate as subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Goto |
Organization
Juntendo university Shizuoka hospital
Division name
Drug department
Zip code
Address
1129, Nagaoka, Izunokuni-shi, Shizuoka
TEL
0559483111
a-gotou@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Goto |
Organization
Juntendo university Shizuoka hospital
Division name
Drug department
Zip code
Address
1129, Nagaoka, Izunokuni-shi, Shizuoka
TEL
0559483111
Homepage URL
a-gotou@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university Shizuoka hospital, Drug department
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 01 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033893
