UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013616 |
|---|---|
| Receipt number | 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 18:24:32 |
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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
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
mch1031@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital Respiratory center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015504
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
