UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045193 |
|---|---|
| Receipt number | R000051628 |
| Scientific Title | Analysis and Instruction of inhaling flow patter through Turbuhaler or Discus in the patients with obstructive lung diseases |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2022/08/19 09:20:46 |
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Basic information
Public title
Improvement by the fact of the inhalational style in the inhaler of the patients with obstructive lung disease and the inhalational instruction
Acronym
Improvement by a fact and the instruction of the inhalation of the obstructive lung disease therapeutic drug
Scientific Title
Analysis and Instruction of inhaling flow patter through Turbuhaler or Discus in the patients with obstructive lung diseases
Scientific Title:Acronym
Improvement of the actual situation of the inhalational style from Turbuhaler (TBH) or discus (DKS) and the inhalational instruction
Region
| Japan |
Condition
Condition
obstructive lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An inhalational therapeutic drug of the asthma bronchial includes a discus in Turbuhaler, but we make patients with each inhale it and measure real inhalation pattern and drug burst size and prove that we teach inhalation if inappropriate inhalation is performed, and improvement is obtained.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure the maximal inspiration speed and drug burst size of 2-4 weeks.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Person age 18 years old or older
The patients with asthma bronchial to COPD (each definition follows guidelines on GOLD which is international criteria and GNA)
The person who obtained written consent by the free will of the person in response to enough explanation on participating to one of this study
The inhalation that is inappropriate in initial evaluation and the person who was judged
Key exclusion criteria
The person whom adherence of the inhalation has bad (inhalant rate of use less than 70%)
Patients with severe COPD (anti-predicted value forced expiratory volume one second percent less than 49%)
The person who is complicated with heart failure, neuromuscular disorders of the patients altitude with chronic respiratory tract infection
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | SAKURAKO |
| Middle name | |
| Last name | TAJIRI |
Organization
Tokai University Oiso Hospita
Division name
Respiratory Medicine
Zip code
2591141
Address
21-1
TEL
0463723211
sakurako@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | SAKURAKO |
| Middle name | |
| Last name | TAJIRI |
Organization
Tokai University Oiso Hospital
Division name
Respiratory Medicine
Zip code
2591141
Address
Gakkyo, Oiso-machi, Naka-gun, Kanagawa 21-1
TEL
0463723211
Homepage URL
sakurako@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
No
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
Tokai University Ethical Review Board
Address
143, Shimokasuya, Isehara-shi, Kanagawa
Tel
0463931121
sakurako@is.icc.u-tokai.ac.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 | 08 | Month | 18 | 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
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When improvement of inhalational speed and the drug burst size is obtained by inhalational instruction, we expect it
Management information
Registered date
| 2021 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051628
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
