UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005188 |
|---|---|
| Receipt number | R000006158 |
| Scientific Title | The effect of standard treatments in COPD patients without maintenance therapy. |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2015/09/03 20:38:26 |
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Basic information
Public title
The effect of standard treatments in COPD patients without maintenance therapy.
Acronym
The effect of standard treatments in COPD patients without maintenance therapy.
Scientific Title
The effect of standard treatments in COPD patients without maintenance therapy.
Scientific Title:Acronym
The effect of standard treatments in COPD patients without maintenance therapy.
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of standard therapy in COPD patients without maintenance therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of pulmonary function (trough FEV1 and trough FVC)
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 | Behavior,custom |
Interventions/Control_1
Maintenance therapy in accordance with Japanese COPD guideline
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of COPD by respiratory specialist.
Not receiving of maintenance therapy with LABA, LAMA and ICS
Patients who are judged to be included in the study by investigator based on a preliminary clinical examination.
Written Informed Consent Form prior to participation in the trial.
Key exclusion criteria
A known hypersensitivity to the components of each standard drug for COPD.
Known diseases which contraindicate using the standard drugs for COPD according to the package insert.
Patients who are judged not to be included in the study by investigator based on a preliminary clinical examination.
Not able to follow an instruction for a smoking cessation.
A history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
Not able to perform pulmonary function tests.
Participation in another trial with an investigational drug within 2 month prior to informed consent visit.
Pregnant or nursing women or women of childbearing potential who are not using a medically approved means of contraception.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Setoguchi |
Organization
Tokyo Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
6-7-1 Nishi-Shinjyuku, Shinjyuku-ku, Tokyo
TEL
+81-3-3342-6111
ystgc@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Setoguchi |
Organization
Tokyo Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
6-7-1 Nishi-Shinjyuku, Shinjyuku-ku, Tokyo
TEL
+81-3-3342-6111
Homepage URL
ystgc@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Public health research center
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 29 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 19 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2015 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006158
