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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013616
Receipt No. R000015504
Scientific Title Effect of mono or dual broncholdilator therapy on daily step count and six minutes walking distance in COPD patients.
Date of disclosure of the study information 2014/05/07
Last modified on 2019/03/14

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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
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
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

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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