UMIN-CTR Clinical Trial

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

chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

respiratory resistance and reactance on IOS

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ystgc@tokyo-med.ac.jp

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

Email

ystgc@tokyo-med.ac.jp

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name

Organization

Tokyo Medical University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

17

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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