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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003174
Receipt No. R000003419
Scientific Title The effects of inhaled procaterol on COPD patients.
Date of disclosure of the study information 2010/02/12
Last modified on 2011/08/17

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Basic information
Public title The effects of inhaled procaterol on COPD patients.
Acronym The effects of inhaled procaterol on COPD patients.
Scientific Title The effects of inhaled procaterol on COPD patients.
Scientific Title:Acronym The effects of inhaled procaterol on COPD patients.
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease (COPD)
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find the clinical parameters which associtate with the effectiveness of inhaled procaterol in COPD patitents.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The collerations between clinical and functional parameters and the effects procaterol inhalation on lung function, dyapnea and exercise performance (6MW) in patients with COPD .
Key secondary outcomes Adverse event

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Inhalation of procaterol
Interventions/Control_2 Inhalation of 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
30 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Able and willing to read, understand, and provide written Informed Consent;
2.Age range of 30-80 years;
FEV1%<70% after bronchodilator inhalation
Diagnosed as COPD
%FEV1<80%
MRC dyspnea grade >=1
Chest CT within 6 months
Key exclusion criteria History of exacerbation in the previous 8 weeks
Co-morbid conditions (heart diseases or neuromuscular diseases) limiting exercise.
The other significant conditions that seem to limit study protocol.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School of Medicine
Division name Respiratory and Infectious Diseases
Zip code
Address 2-16-1Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School of Medicine
Division name Respiratory and Infectious Diseases
Zip code
Address 2-16-1Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute St.Marianna University School of Medicine
Respiratory and Infectious Diseases
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 12 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 Completed
Date of protocol fixation
2010 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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
2010 Year 02 Month 12 Day
Last modified on
2011 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003419

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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