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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015609
Receipt No. 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

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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
Last 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
Email suda@hama-med.ac.jp

Public contact
1st 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
Email fujisawa@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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