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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017042
Receipt No. 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

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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
Email 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
Email hozawa@vesta.ocn.ne.jp

Sponsor
Institute Hiroshima Allergy and Respiratory Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019763

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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