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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006739
Receipt No. 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

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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
Email 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
Email sugiyama@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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