UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008268 |
|---|---|
| Receipt number | R000009747 |
| Scientific Title | Comparison between indacaterol and tiotropium on respiratory function and exercise tolerance in COPD patients |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2013/01/18 16:28:35 |
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Basic information
Public title
Comparison between indacaterol and tiotropium on respiratory function and exercise tolerance in COPD patients
Acronym
Efficacy of indacaterol vs. tiotropium in COPD
Scientific Title
Comparison between indacaterol and tiotropium on respiratory function and exercise tolerance in COPD patients
Scientific Title:Acronym
Efficacy of indacaterol vs. tiotropium in COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compair efficacy between indacaterol and tiotropium, the prospective study is planned with respiratory function and exercise tolarence in COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory function and 6 minutes walk test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A
tiotropium18microgram(more than 2 months)indacaterol 150microgram(2 months)tiotropium18microgram(2 months)
Interventions/Control_2
Group B
tiotropium18microgram(more than 2 months)tiotropium18microgram(2 months)
indacaterol 150microgram(2 months)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
COPD outpatients who consent to this clinical research
Key exclusion criteria
patients who had admitted due to COPD exacerbation in 6 weeks
patients who had bronchial infection in 6 weeks
patients who had asthma in past
pregnant women and women who may be in pregnancy
patients who have severe complications as heart diseases, liver disfunction and renal disfunction
patients who doctors regarded unsuitable for this trial
patients who had allergy for the ingredients of these medicine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Kanazawa |
Organization
Saitama Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
38 Morohongou Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Suzuki |
Organization
Saitama Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
38 Morohongou Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1319
Homepage URL
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2013 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009747
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
