UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005101 |
|---|---|
| Receipt number | R000006059 |
| Scientific Title | Examination of effect and safety of short acting beta2 agonist in stability period COPD patient(Acute effect and chronic effect) |
| Date of disclosure of the study information | 2011/02/17 |
| Last modified on | 2011/03/31 23:29:16 |
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Basic information
Public title
Examination of effect and safety of short acting beta2 agonist in stability period COPD patient(Acute effect and chronic effect)
Acronym
Examination of effect and safety of short acting beta2 agonist in stability period COPD patient(-Acute effect and chronic effect)
Scientific Title
Examination of effect and safety of short acting beta2 agonist in stability period COPD patient(Acute effect and chronic effect)
Scientific Title:Acronym
Examination of effect and safety of short acting beta2 agonist in stability period COPD patient(-Acute effect and chronic effect)
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect and safety of the short acting beta2 agonist on losing breath of the COPD patient of the stability period are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
St.George' s Respiratory Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
short acting beta2 agonist
Interventions/Control_2
placebo
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.It is COPD patient of a possible outpatient care in the this hospital.
2.The severity of symptoms : from the middle syndrome to the serious illness in the GOLD guideline.
3.The age is 85 years old from 40 years old.
Key exclusion criteria
1.Amalgamation of bronchitic asthma
2.When the beta2 stimulation medicine is a taboo
3.Additionally, person who seems to be improper examination doctor in charge it
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiko Miura |
Organization
TOHOKU ROSAI HOSPITAL
Division name
Respiratory
Zip code
Address
3-21,4-chome,Dainohara,Aoba-ward,Sendai-city,Miyagi
TEL
022-275-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Nihei |
Organization
TOHOKU ROSAI HOSPITAL
Division name
Respiratory
Zip code
Address
TEL
022-275-1111
Homepage URL
Sponsor or person
Institute
TOHOKU ROSAI HOSPITAL,Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
TOHOKU ROSAI HOSPITAL,Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Internal Medicine, NTT East Tohoku Hospital
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
東北労災病院、NTT東日本東北病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2011 | Year | 02 | Month | 17 | Day |
Last modified on
| 2011 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006059
