UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025049 |
|---|---|
| Receipt number | R000028828 |
| Scientific Title | The effectiveness of switching to Tiotropium / Olodaterol combination in patients with COPD |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2022/06/06 13:10:03 |
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Basic information
Public title
The effectiveness of switching to Tiotropium / Olodaterol combination in patients with COPD
Acronym
The effectiveness of switching to Tiotropium / Olodaterol combination
Scientific Title
The effectiveness of switching to Tiotropium / Olodaterol combination in patients with COPD
Scientific Title:Acronym
The effectiveness of switching to Tiotropium / Olodaterol combination
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of switching from Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol combination in COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FEV1 between week 0 and week 8
Key secondary outcomes
Change in FVC between week 0 and week 8
Change in FOT parameters between week 0 and week 8
Change in CAT between week 0 and week 8
Change in mMRC between week 0 and week 8
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
Switching from Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol combination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Diagnosis of moderate-to-severe COPD.
-Post-bronchodilator FEV1/FVC < 70%.
-Post bronchodilator FEV1 < 80% predicted normal.
-Smoking history of 10 pack-years or more.
-Patients treated with Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol.
Key exclusion criteria
-Patients with a history of asthma.
-Patients who are already treated with ICS or oral corticosteroid regularly.
-Patients who have experienced a COPD exacerbation within the previous 8 weeks.
-Patients with uncontrolled cardiac diseases.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taisuke |
| Middle name | |
| Last name | Akamatsu |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
4208527
Address
4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL
054-247-6111
taisuke-akamatsu@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Akamatsu |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
4208527
Address
4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL
054-247-6111
Homepage URL
taisuke-akamatsu@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Clinical Research Ethics Board
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
Tel
054-247-6111
chiken-sougou@shizuoka-pho.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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.scirp.org/journal/paperinformation.aspx?paperid=98170
Number of participants that the trial has enrolled
57
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028828
