UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011958 |
|---|---|
| Receipt number | R000013968 |
| Scientific Title | Combination therapy with tiotopium and indacaterol in patients with COPD |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2016/06/30 07:21:21 |
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Basic information
Public title
Combination therapy with tiotopium and indacaterol in patients with COPD
Acronym
Combination therapy with tiotropium and indacaterol in COPD
Scientific Title
Combination therapy with tiotopium and indacaterol in patients with COPD
Scientific Title:Acronym
Combination therapy with tiotropium and indacaterol in COPD
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 evaluate the usefulness of combination therapy with tiotropium and indacaterol, in patients with COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of values in respiratory function tests
Key secondary outcomes
QOL, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tiotropium 18 microg and indacaterol 150 microg
Interventions/Control_2
Indacaterol 150 microg and tiotropium 18 microg
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
Patients with chronic obstructive pulmonary disease
Patients can use the inhaled therapy
Patients gave written informed consent
Key exclusion criteria
History of hypersensitivity to tiotropium and indacaterol
Patients with bronchial asthma
Patients during acute exacerbation
Presence of infectious disease, pneumothorax, and severe heart failure
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal medicine
Zip code
Address
1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsushima Sayomi |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal medicine
Zip code
Address
1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2263
Homepage URL
sayomimatsu@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
浜松医科大学 (静岡県)
静岡県立総合病院 (静岡県)
浜松労災病院 (静岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 07 | 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
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 04 | Day |
Last modified on
| 2016 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013968
