UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008384 |
|---|---|
| Receipt number | R000009856 |
| Scientific Title | Comparison of the effect of indacaterol versus salmeterol in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2012/07/10 |
| Last modified on | 2016/03/22 16:29:10 |
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Basic information
Public title
Comparison of the effect of indacaterol versus salmeterol in patients with chronic obstructive pulmonary disease
Acronym
Comparison of the effect of indacaterol versus salmeterol in patients with chronic obstructive pulmonary disease
Scientific Title
Comparison of the effect of indacaterol versus salmeterol in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Comparison of the effect of indacaterol versus salmeterol in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the objective and subjective effects of indacaterol compared with other LABAs in COPD patients who were on tiotropium therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of indacaterol on FEV1 compared with other LABAs in patients with COPD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
150microgram once daily Indacaterol
Interventions/Control_2
Other LABAs(50microgram twice daily salmeterol or 2mg transdermal tulobuterol)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients able to understand and sign the Informed Consent Form.
2. Subjects above 30 years of age with a formal diagnosis of COPD and , meeting all of the following criteria.
a) FEV1/forced vital capacity <0.7 measured within 30 min of inhaling
beta2 agonist.
b) FEV1 < 80% of predicted value.
c) Patients currently treated with tiotropium.
d) Patients presenting with COPD dyspnea symptoms (mMRC =/> 1) despite
treatment of tiotropium.
Key exclusion criteria
1. Patients experienced acute exacerbation within 8 weeks before the start of this study.
2. Patients with an unstable cardiac diseases.
3. Patients deemed as inappropriate for this study by investigators.
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
2-16-1,Sugao,Miyamaeku,Kawasaki-City
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
TEL
Homepage URL
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Respiratory and infectious diseases
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
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
聖マリアンナ医科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 10 | 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
| 2011 | Year | 12 | Month | 01 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009856
| 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 |
