UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017042 |
|---|---|
| Receipt number | R000019763 |
| Scientific Title | Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma in 4-week treatment;Open-label, randomized, parallel-group comparative study |
| Date of disclosure of the study information | 2015/04/04 |
| Last modified on | 2015/04/04 10:46:32 |
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Basic information
Public title
Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate
/vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma in 4-week treatment;Open-label, randomized, parallel-group comparative study
Acronym
Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma
Scientific Title
Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate
/vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma in 4-week treatment;Open-label, randomized, parallel-group comparative study
Scientific Title:Acronym
Budesonide/formoterol maintenance reliever therapy versus fluticasone furoate /vilanterol fixed-dose treatment of asthma on airway inflammation with adult asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japanese asthma patients,the clinical study that compared the airway inflammation improvement effect of fluticasone furoate/vilanterol of once-daily with regular medication of budesonide/formoterol has not been yet reported. In addition, there is not the study that compared the medication in once-daily use with it in twice daily use in Japanese patients.
Therefore, the purpose of this study is to compare the effect on airway inflammation in once-daily use of fluticasone furoate/vilanterol with regular and on-demand use of budesonide/formoterol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of amount of change in FeNO with NIOXmino between baseline and after 4 weeks treatment
Key secondary outcomes
The comparison of the effect in the following background factors after 4week treatment;
ACQ score
Airway resistance with IOS
FEV1.0
Frequency of SABA use
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Budesonide160 mcg/Formoterol4.5 mcg once 2 inhalation,twice daily
Interventions/Control_2
Fluticasone furoate100 mcg
/vilanterol2 mcg once 1 inhalation,once 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who completely fills the following criteria
1)Man or woman who is 20 years old or older at the time getting informed consent
2)Patient who is diagnosed with asthma
3)Patient who had been administered inhaled corticosteroids of medium dose at 12 weeks over the past
4)Patient who has Value of FeNO more than 35 ppb
Inhaled steroids of medium dose, Budesonide(BUD)400-800 mcg/day, or, beclomethasone(BDP-HFA), fluticasone (FP-DPI,HFA), ciclesonide(CIC-HFA), mometasone(MF-DPI)is defined as a 200-400 mcg/day
Key exclusion criteria
The patient with the following exclusion criteria is not enrolled
1)Patient with the drug allergy
2)Infection in the absence of effective antimicrobial agents, patients with deep mycosis
3)Patient with tuberculous disease, or respiratory infection
4)Patient with abnormal chest X-ray image
5)Patient with respiratory disease and other respiratory infections in 8 weeks before inclusion
6)Patient is using the beta-blockers, including eye drops or patients with systemic corticosteroids to less than 30 days
7)Patient with serious complications
8)Smoking history of 10 pack years or more and with less than 6 months or by non smoking
9)Patient with pregnancy, or who hope for a pregnancy
10)Patient was deemed inappropriate research attending physician is incorporated into this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichiro Hozawa |
Organization
Hiroshima Allergy and Respiratory Clinic
Division name
Department of Respiratory medicine
Zip code
Address
Daiichi-Teraoka building 6F, 1-9-28,Hikari-maci, Higashi-ku, Hiroshima city, Hiroshima, Japan
TEL
082-568-1167
hozawa@vesta.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichiro Hozawa |
Organization
Hiroshima Allergy and Respiratory Clinic
Division name
Department of Respiratory medicine
Zip code
Address
Daiichi-Teraoka building 6F, 1-9-28,Hikari-maci, Higashi-ku, Hiroshima city, Hiroshima, Japan
TEL
082-568-1167
Homepage URL
hozawa@vesta.ocn.ne.jp
Sponsor or person
Institute
Hiroshima Allergy and Respiratory Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 04 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | 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
| 2015 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019763
| Research Plan | |
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| 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 |
