UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043787 |
|---|---|
| Receipt number | R000049986 |
| Scientific Title | The efficacy of education for inhalation technique in outpatients with bronchial asthma |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/03/30 21:00:21 |
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Basic information
Public title
The efficacy of education for inhalation technique in outpatients with bronchial asthma
Acronym
Clinical trial on education for inhalation technique in outpatients with bronchial asthma
Scientific Title
The efficacy of education for inhalation technique in outpatients with bronchial asthma
Scientific Title:Acronym
Clinical trial on education for inhalation technique in outpatients with bronchial asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of education for
inhalation techinique in outpatients with
bronchial asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ACT score change in asthmatic condition by education for inhalation technique
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
education for inhalation technique for 3 months
Interventions/Control_2
no education for inhalation technique
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
asthma or asthma and COPD overlap( ACO) who
first treated inhaler.
Key exclusion criteria
1)other respiratory disease except asthma
2)severe heart disease
3)malignant disease
4)active infectious disease
5)pneumothorax
6)judged inadequate to participate in the study by the physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Honjo |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Nursing department
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552
TEL
+81668532001
honjo.ayako.kj@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Honjo |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Nursing department
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552
TEL
+81668532001
Homepage URL
honjo.ayako.kj@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Clinical Research from National Hospital Organization
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
National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552
Tel
+81668532001
410-chiken@mail.hosp.go.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 | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049986
