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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name