UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039915 |
|---|---|
| Receipt number | R000045494 |
| Scientific Title | Usefulluness of single inhalaer treatment with long acting muscarinic antagonist, long acting beta agosit, and inhaled corticosteroid in symptomatic patients with symptomatic chronic obstructive pulmonary disease without asthma and exacerbation |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2020/03/23 18:51:37 |
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Basic information
Public title
Usefulluness of single inhalaer treatment with long acting muscarinic antagonist, long acting beta agosit, and inhaled corticosteroid in symptomatic patients with chronic obstructive pulmonary disease without asthma and exacerbation
Acronym
Triple therapy for symptomatic COPD without asthma and exacerbation
Scientific Title
Usefulluness of single inhalaer treatment with long acting muscarinic antagonist, long acting beta agosit, and inhaled corticosteroid in symptomatic patients with symptomatic chronic obstructive pulmonary disease without asthma and exacerbation
Scientific Title:Acronym
Triple therapy for symptomatic COPD without asthma and exacerbation
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
GOLD guide line recommends triple therapy with dual long acting bronchodilator and inhaled corticosteroid in COPD patients with frequent exacerbation, while Japanese Respiratory Society guideline recommends such therapy for COPD patients with asthma. However, the usefullnes of triple therapy in symptomatic COPD patients without asthma and exacerbation is not clarified. To investigate the usefullness of triple therapy in in symptomatic COPD patients without asthma, we conducted a prospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in chronic COPD assesement test score and % forced expiratory capacity in 1 second before and 8 and 24 weeks after the initiation of triple therapy
Key secondary outcomes
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 inhaler with umeclidinium bromide, vilanterol trifenatate, and fulticasone furoate
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
Symptomatic COPD patients who are recieving single inhaler treatment with long acting beta agonist and long acting muscarinic antagonist and do not have asthma and exacerbation history
Key exclusion criteria
Asmptomatic COPD patients, asthma COPD overlap patients, COPD patients with exacerbation history, COPD patients with malignancy, COPD patients with other serious medical conditions, and COPD patients who were judged to be unsuitable for this study by attending physicians
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mikio |
| Middle name | |
| Last name | Toyoshima |
Organization
Hamamatsu Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
430-8525
Address
25 Shogencho, Hamamatsu
TEL
0534621211
mi-toyoshima@hamamatsuh.johas.go.jp
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Toyoshima |
Organization
Hamamtsu Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
430-8525
Address
25 Shogencho, Hamamatsu
TEL
0534621211
Homepage URL
mi-toyoshima@hamamatsuh.johas.go.jp
Sponsor or person
Institute
Hamamatsu Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Rosai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamtsu Rosai Hospital
Address
25 Shogencho, Hamamatsu
Tel
0534621211
mi-toyoshima@hamamatsuh.johas.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045494
| 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 |
