UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037646 |
|---|---|
| Receipt number | R000042930 |
| Scientific Title | Prospective study for detect the daily activity and efficacy of medication of COPD patients using wearable watch type sensor. |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2019/08/09 11:58:08 |
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Basic information
Public title
Prospective study for detect the daily activity and efficacy of medication of COPD patients using wearable watch type sensor.
Acronym
Ditection of daily activity of COPD patients using uearable sensor.
Scientific Title
Prospective study for detect the daily activity and efficacy of medication of COPD patients using wearable watch type sensor.
Scientific Title:Acronym
Ditection of daily activity of COPD patients using uearable sensor.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detect the daily activity of COPD patinets using wearable activity sensor. After that study the effect of LAMA (Tiotropium) and LAMA/LABA (Tiotropium/Olodaterol) for daily activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Daily activity for 6 weeks with the test drugs.
Key secondary outcomes
Daily activity for 3 weeks with observational period.
Time coarse of CAT score and mMRC score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Comparison between LAMA and LAMA,LABA.
All the patients will be administered LAMA (Tiotropium) for 6 weeks.
Interventions/Control_2
Comparison between LAMA and LAMA,LABA.
All the patients will be administered LAMA (Tiotropium) for 6 weeks after that randamaized to 2 groups LAMA and LAMA,LABA (Tiotropium,Olodaterol) for 6 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COPD patients.
Key exclusion criteria
Other pulmonary diseases like lung cancer interstitial pneumonia, pulmonary infection and so on.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Motokazu |
| Middle name | |
| Last name | Kato |
Organization
Kishiwada City Hospital
Division name
Chest Disease Clinical and Research Institute
Zip code
596-8501
Address
1001 Gakuhara-cho, Kishiwada, Osaka, Japan.
TEL
072-445-1000
kch-43@kishiwada-hospital.com
Public contact
Name of contact person
| 1st name | Motokazu |
| Middle name | |
| Last name | Kato |
Organization
Kishiwada City Hospital
Division name
Chest Disease Clinical and Research Institute
Zip code
596-8501
Address
1001 Gakuhara-cho, Kishiwada, Osaka, Japan.
TEL
072-445-1000
Homepage URL
kch-43@kishiwada-hospital.com
Sponsor or person
Institute
Chest Disease Clinical and Research Institute, Kishiwada City Hospital.
Institute
Department
Personal name
Funding Source
Organization
Chest Disease Clinical and Research Institute, Kishiwada City Hospital.
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
Ethical Comittie, Kyoto University.
Address
Shogoin-Kawaramachi, Sakyo, Kyoto.
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
岸和田市民病院呼吸器センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042930
