UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001489 |
|---|---|
| Receipt number | R000001807 |
| Scientific Title | Reduced airway inflammation of smokers with statins |
| Date of disclosure of the study information | 2008/11/08 |
| Last modified on | 2008/11/08 18:37:44 |
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Basic information
Public title
Reduced airway inflammation of smokers with statins
Acronym
Reduced airway inflammation of smokers with statins
Scientific Title
Reduced airway inflammation of smokers with statins
Scientific Title:Acronym
Reduced airway inflammation of smokers with statins
Region
| Japan |
Condition
Condition
smokers
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate statins improve the airway inflammation of skokers and COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inflammatory cytokines, chemokines and growth factors in the ELF
Key secondary outcomes
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 |
Interventions/Control_1
statins medication
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
smokers taking a bronchoscopic examination
Key exclusion criteria
patients with lver disfunction, renal disfunction or ischemic heart diseases
patients taking medication which occurs drug interaction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahashi Saeko |
Organization
Kawasaki minicipal hospital
Division name
internal medicine
Zip code
Address
12-1Shinkawa-toori Kawasaki-ku Kakawasaki-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahashi Saeko |
Organization
Kawasaki minicipal hospital
Division name
internal medicine
Zip code
Address
TEL
Homepage URL
taksae@gf7.so-net.ne.jp
Sponsor or person
Institute
Division of pumonary medicine,Department of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Division of pumonary medicine,Department of Medicine, Keio University
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
| 2008 | Year | 11 | Month | 08 | 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
Date of protocol fixation
| 2008 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 08 | Day |
Last modified on
| 2008 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001807
