UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047506 |
|---|---|
| Receipt number | R000049549 |
| Scientific Title | Effects of fluticasone furoate, vilanterol and umeclidinium bromide on asthma |
| Date of disclosure of the study information | 2022/04/17 |
| Last modified on | 2023/10/18 22:30:29 |
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Basic information
Public title
Effects of fluticasone furoate, vilanterol and umeclidinium bromide on moderate or severer asthmatic patients
Acronym
Effects of fluticasone furoate, vilanterol and umeclidinium bromide on asthma
Scientific Title
Effects of fluticasone furoate, vilanterol and umeclidinium bromide on asthma
Scientific Title:Acronym
Fluticasone furoate, vilanterol and umeclidinium bromide on asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of fluticasone furoate, vilanterol and umeclidinium bromide on moderate or severer asthmatic patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung function tests and/or asthma control tests
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Moderate or severer asthma
Key exclusion criteria
Subjects who did not agree with the participation of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of Respiratory Medicine, Shioya Hospital
Zip code
329-2145
Address
Tomita 77, Yaita-City, Tochigi
TEL
0287441155
umeda@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of General Medicine, School of Medicine
Zip code
158-0081
Address
3-28-2 Fukasawa, Setagaya-ku, Tokyo
TEL
0357074510
Homepage URL
aumeda@hf.catv.ne.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare Shioya Hospital
Address
Tomita 77, Yaita-City, Tochigi Prefecture
Tel
0287441155
umeda@iuhw.ac.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
| 2022 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fphys.2023.1131949/full?fbclid=IwAR1wkmZvtZu-0kl278XJlc
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fphys.2023.1131949/full?fbclid=IwAR1wkmZvtZu-0kl278XJlc
Number of participants that the trial has enrolled
114
Results
Inhaled drugs were switched to FF/UMEC/VI 200/62.5/25 microgram for asthma patients. Peripheral and small airways were found to be dilated.
Results date posted
| 2023 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Asthma patients with moderate symptoms or severer
Participant flow
Inhaled drugs were switched to FF/UMEC/VI 200/62.5/25 microgram and lung function tests were performed
Adverse events
Localside effects like disconfort sensations in the throat
Outcome measures
Lung function tests
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of using drugs which were permitted to use by Japanese drug use system.
Management information
Registered date
| 2022 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049549
