UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006739 |
|---|---|
| Receipt number | R000007960 |
| Scientific Title | The relationship between asthma management and inhaler technique training |
| Date of disclosure of the study information | 2011/11/17 |
| Last modified on | 2020/04/07 12:53:01 |
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Basic information
Public title
The relationship between asthma management and inhaler technique training
Acronym
The relationship between asthma management and inhaler technique training
Scientific Title
The relationship between asthma management and inhaler technique training
Scientific Title:Acronym
The relationship between asthma management and inhaler technique training
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis for the effect on inhaler technique training for asthma management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence
ACT
FEV1
FeNO
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
without inhaler technique training.
Interventions/Control_2
with inhaler technique training.
Interventions/Control_3
with inhaler technique training and education.
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
1. ACT score is under 24.
2. SFC or discus was not used for previous 6 months
Key exclusion criteria
1. Discus is already used.
2. ACT score is 25.
3. Respiratory disease is contracted
4. Have allergy for SFC
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Fukuda |
Organization
Dokkyo Medical University
Division name
Dept. of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282861111
t-fukuda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiya Sugiyama |
Organization
Dokkyo Medical University
Division name
Dept. of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282861111
Homepage URL
sugiyama@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
| 2011 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
https://doi.org/10.15036/arerugi.62.1396_2
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.15036/arerugi.62.1396_2
Number of participants that the trial has enrolled
Results
Inhalation instruction was very useful for patients with poor controlled asthma.
Results date posted
| 2019 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with asthma (man:female = 2:3, mean age 59.4 year old)
Participant flow
After informed consent, asthma diary with peak flow rate was kept. Inhalation instructions were performed after two and four months.
Adverse events
none
Outcome measures
ACT score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007960
