UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination therapy with tiotopium and indacaterol in patients with COPD
Title of the study (Brief title)	Combination therapy with tiotropium and indacaterol in COPD
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease (COPD)
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of combination therapy with tiotropium and indacaterol, in patients with COPD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of values in respiratory function tests
Key secondary outcomes	QOL, safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Tiotropium 18 microg and indacaterol 150 microg
Interventions/Control_2	Indacaterol 150 microg and tiotropium 18 microg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic obstructive pulmonary disease Patients can use the inhaled therapy Patients gave written informed consent
Key exclusion criteria	History of hypersensitivity to tiotropium and indacaterol Patients with bronchial asthma Patients during acute exacerbation Presence of infectious disease, pneumothorax, and severe heart failure
Target sample size	80

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal medicine
Address	1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Matsushima Sayomi
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal medicine
Address	1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL	053-435-2263
Homepage URL
Email	sayomimatsu@yahoo.co.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	浜松医科大学　(静岡県)　 静岡県立総合病院 (静岡県) 浜松労災病院 (静岡県)

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 31 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 04 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013968