UMIN-CTR Clinical Trial

Basic information
Public title	Effect of mono or dual broncholdilator therapy on daily step count and six minutes walking distance in COPD patients.
Acronym	Matsusaka Municipal Hospital COPD study
Scientific Title	Effect of mono or dual broncholdilator therapy on daily step count and six minutes walking distance in COPD patients.
Scientific Title:Acronym	Matsusaka Municipal Hospital COPD study
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of long acting B2-agonist and long-acting muscarinic antagonist on physical activity in COPD patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Average number of steps/day
Key secondary outcomes	Spirometry Quality of life 6-min walking distance test

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single-arm trial(35 patients) Interventions will include 1)no-therapy for 3-to-4 weeks, 2)therapy with long-acting muscarinic antagonist alone for 3-to-4 weeks and 3)therapy with a combination of long-acting B2-agonist and long-acting muscarinic antagonist for 3-to-4 weeks
Interventions/Control_2
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	COPD patients that fulfil the GOLD criteria and patients that agree to provide informed consent will be included.
Key exclusion criteria	1.Patients with other serious clinical morbidities or complications will be excluded. 2.Patients with bronchial asthma 3.History of hypersensitivity to indacaterol and glycopyrronium 4.Patients during acute exacerabation 5.Patients who are judged improper to the test by an examination responsibility doctor's judgement
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Osamu Hataji
Organization	Matsusaka Municipal Hospital
Division name	Respiratory center
Zip code
Address	1550 Tonomachi,Matsusaka,Mie
TEL	0598-23-1515
Email	mch1031@city-hosp.matsusaka.mie.jp

Public contact
1st name of contact person	1st name Middle name Last name Osamu Hataji
Organization	Matsusaka Municipal Hospital
Division name	Respiratory center
Zip code
Address	1550 Tonomachi,Matsusaka,Mie
TEL	0598-23-1515
Homepage URL
Email	mch1031@city-hosp.matsusaka.mie.jp

Sponsor
Institute	Matsusaka Municipal Hospital Respiratory center
Institute
Department

Funding Source
Organization	Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Pulmonary and Critical Care Medicine,Mie University Craduate School of Medicine Department of Immunology,Mie University Graduate School of Medicine
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	松阪市民病院　呼吸器センター

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 07 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	Terminated
Date of protocol fixation	2014 Year 04 Month 01 Day
Date of IRB	2014 Year 04 Month 07 Day
Anticipated trial start date	2014 Year 04 Month 07 Day
Last follow-up date	2014 Year 12 Month 27 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 03 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015504