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Name:
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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008268
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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