UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011564 |
|---|---|
| Receipt number | R000013513 |
| Scientific Title | The additional effect of the respiratory rehabilitation to the COPD patient who did additional medical treatment of budesonide / formoterol at tiotropium |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/08/23 15:40:23 |
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Basic information
Public title
The additional effect of the respiratory rehabilitation to the COPD patient who did additional medical treatment of budesonide / formoterol at tiotropium
Acronym
The additional effect of the respiratory rehabilitation to the COPD patient who did additional medical treatment of budesonide / formoterol at tiotropium
Scientific Title
The additional effect of the respiratory rehabilitation to the COPD patient who did additional medical treatment of budesonide / formoterol at tiotropium
Scientific Title:Acronym
The additional effect of the respiratory rehabilitation to the COPD patient who did additional medical treatment of budesonide / formoterol at tiotropium
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical validity at the time of adding the medical treatment and respiratory rehabilitation which used together budesonide/formoterol to tiotropium for COPD patient is examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise tolerability by 6-minute walk distance
The amount of body activities by an active mass meter
Key secondary outcomes
Respiratory function
Condition score (CAT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom | Maneuver |
Interventions/Control_1
BUD/folmoterol ,Respiratory rehabilitation
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) An outpatient aged 40 and over in the age at the time of agreement acquisition
(b) The patient who has the condition of COPD and will have a smoking history equivalent to 10 or more pack year of patients (c) currently diagnosed as COPD from two years or more before
(d) He is a ten or more CAT questionnaires patient at Visit1.
Key exclusion criteria
(a) The patient who has BUD/FM in preliminary medication
(b) The patient who has received hospitalization or the whole body, inhalation steroid medicine medication, and medication of the antibiotic within one month before the examination
(c) The patient who has received the domiciliary oxygen therapy periodically
(d) A patient with the past of bronchial asthma
(e) The patient who has the past of hypersensitivity in BUD/FM
(f) The patient who has chronic diseases, such as a lung, the heart, the kidney, liver, and blood
(g) The patient who has an anamnesis of adrenal cortical insufficiency
(h) The patient who judged test inclusion to be improper by an examination responsibility doctor's judgment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SUSUMU IWATA |
Organization
Komaki City Hospital
Division name
Respiratory division
Zip code
Address
Joubusi1-20, Komaki-City, Aichi,Japan
TEL
0568764131
sin@komakihp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SUSUMU IWATA |
Organization
Komaki City Hospital
Division name
Respiratory division
Zip code
Address
Joubusi1-20, Komaki-City, Aichi,Japan
TEL
0568764131
Homepage URL
sin@komakihp.gr.jp
Sponsor or person
Institute
Komaki City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2013 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 23 | Day |
Last modified on
| 2013 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013513
| Research Plan | |
|---|---|
| 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 |
