UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043481 |
|---|---|
| Receipt number | R000049646 |
| Scientific Title | Trelegy Ellipta for Real Asthma Control Study |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/01 14:36:49 |
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Basic information
Public title
Trelegy Ellipta for Real Asthma Control Study
Acronym
T-RECS study
Scientific Title
Trelegy Ellipta for Real Asthma Control Study
Scientific Title:Acronym
T-RECS study
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical usefulness by the switching from ICS-LABA or ICS-LAMA to triple therapy drugs of Trelegy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FEV1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ICS-LABA-LAMA 100 3 Ms
Interventions/Control_2
ICS-LABA-LAMA 200 3 Ms
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with asthma symptoms
Patients prescribed ICS-LABA or ICS-LAMA
Key exclusion criteria
No asthma symptoms
Complications with lung cancer or infections
Smoking more than 10 pack-yeras
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Shimizu |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL
0282872151
yasuo-s@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitomo |
| Middle name | |
| Last name | Kushima |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL
0282872151
Homepage URL
kushima@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Support Division for Clinical Research
Address
880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
R-43-5J
Org. issuing International ID_1
R-43-5J
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049646
| 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 |
