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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005101
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute TOHOKU ROSAI HOSPITAL,Department of Respiratory Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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