UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015609 |
|---|---|
| Receipt number | R000018104 |
| Scientific Title | Comparison of clinical efficacy between twice-daily formoterol/budesonide combinations and once-daily fluticasone furoate/vilanterol in bronchial asthma |
| Date of disclosure of the study information | 2014/11/05 |
| Last modified on | 2017/07/13 20:33:12 |
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Basic information
Public title
Comparison of clinical efficacy between twice-daily formoterol/budesonide combinations and once-daily fluticasone furoate/vilanterol in bronchial asthma
Acronym
Comparison of clinical efficacy between formoterol/budesonide and fluticasone furoate/vilanterol in asthma.
Scientific Title
Comparison of clinical efficacy between twice-daily formoterol/budesonide combinations and once-daily fluticasone furoate/vilanterol in bronchial asthma
Scientific Title:Acronym
Comparison of clinical efficacy between formoterol/budesonide and fluticasone furoate/vilanterol in asthma.
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the efficacy between twice-daily formoterol/budesonide combinations and once-daily fluticasone furoate/vilanterol in patients with persistent asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline (0 week) in FEV1 after 8 weeks of treatment
Key secondary outcomes
Secondly end points are change in QOL (ACT score, ACQ score), fractional exhaled nitric oxide, forced oscillation technique and adherence after 8 weeks of treatment from baseline (0 week). Adverse events are reported throughout the study
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Flticasone Frate/Vilanterol (100/25 ug) once daily
Interventions/Control_2
Two actautions of formoterol/budesonide combinations (160/4.5 ug) twice-daily
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with asthma whose disease was classified as "controlled" according to the GINA criteria of asthma control under the treatment of two actuations of formoterol/budesonide combinations (160/4.5 ug) twice-daily.
Key exclusion criteria
(1) treatment with oral or intravenous corticosteroids in the previous 4weeks, or (2) other pulmonary diseases, including chronic obstructive pulmonary disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fujisawa |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu
TEL
053-435-2263
Homepage URL
fujisawa@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 05 | 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
Forty-two patients with asthma were enrolled (21 patients, pack-year<10) in this study.
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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018104
