UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003174 |
|---|---|
| Receipt number | 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 11:12:22 |
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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
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
Sponsor or person
Institute
St.Marianna University School of Medicine
Respiratory and Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003419
