UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010262 |
|---|---|
| Receipt number | R000012011 |
| Scientific Title | Effects of inhaled indacaterol and inhaled tiotropium on impulse oscillation system (IOS)-assessed measures of peripheral airway resistande and reactance in patients with COPD |
| Date of disclosure of the study information | 2013/03/17 |
| Last modified on | 2015/09/03 20:40:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of inhaled indacaterol and inhaled tiotropium on impulse oscillation system (IOS)-assessed measures of peripheral airway resistande and reactance in patients with COPD
Acronym
Effects of bronchodilator on IOS-assessed measures of peripheral airway resistande and reactance in patients with COPD
Scientific Title
Effects of inhaled indacaterol and inhaled tiotropium on impulse oscillation system (IOS)-assessed measures of peripheral airway resistande and reactance in patients with COPD
Scientific Title:Acronym
Effects of bronchodilator on IOS-assessed measures of peripheral airway resistande and reactance in patients with COPD
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of inhaled indacaterol alone versus inhaled tiotropium alone versus inhaled indacaterol plus inhaled tiotropium on impulse oscillation system (IOS)-assessed measures of peripheral airway resistande and reactance in patients with COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory resistance and reactance on IOS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
150microgram once daily Indacaterol
Interventions/Control_2
18microgram once daily Tiotropium
Interventions/Control_3
150microgram once daily Indacaterol plus18microgram once daily Tiotropium
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient who was diagnosed as COPD.
FEV1/FVC level is within 70% after 15
minutes to one hour used the bate2
agonist on respiratory function test that
it was performed eight weeks ago from
two weeks, and FEV1 level is within 80%
more than 30%
2. Patient that there is sustained dyspnea,
and a symptom maintains the same.
3. 45 years old and more than it, sex no
object.
4. Smoker or patient with the smoking
history.
5. No object according to a thing of
hospitalization / an outpatient, but do
not change the state, during study.
Key exclusion criteria
1. Patient of the symptom that bronchial
asthma is main.
2. Patient who have complications as heart diseases
3. Patient who uses home oxygen
therapy.
4. Patients with a history of
hypersensitivity to Tiotropium or Indacaterol.
5. Patient who was considered ineligible
to use bata2 agonist in a patient
complicated with hyperthyroidism,
hypertension, heart disease and diabetes
mellitus.
6. Woman who are pregnant or breast
feeding, and woman of childbearing
potential.
7. Patient who was considered ineligible
by the investigators.
Target sample size
300
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
Div of Respiratory Medicine, Tokyo Medical University Hospital
TEL
81-3-3342-6111
Homepage URL
ystgc@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 17 | 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
| 2013 | Year | 03 | Month | 17 | 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=R000012011
