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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006553
Receipt No. R000007545
Scientific Title Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Date of disclosure of the study information 2011/10/17
Last modified on 2011/10/17

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Basic information
Public title Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Acronym Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Scientific Title Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Scientific Title:Acronym Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improved effects of Budesonide/Formoterol 160/4.5mcg 2 inhalations bid on peripheral blood eosinophils in patients with asthma with symptoms who used inhaled corticosteroids intermediate dose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in peripheral blood eosinophils
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Budesonide/Formoterol 160/4.5mcg, two inhalations, twice a day, 8 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with bronchial asthma
according to Asthma Prevention and
Management Guideline in Japan
2.Age of 20 years and over, Male and
Female and outpatients
3.Patients who have received
intermediate-dose ICS for at least 4
weeks before enrollment
4."Partly controlled" as defined
according to ASthma Prevention and
Management Guideline in Japan
5.Patients signed written informed
consent
Key exclusion criteria 1.Patients who have past history of
hypersensitivity(including contact
dermatitis)to budesonide, formoterol,
or any component of the combination
2.Patients with infectious disease and/
or deep mycosis that have no effective
antimicrobial agent
3.Patients with tuberculous disease
4.Patients infected with respiratory
tract infectious disease, which may
affect asthma, within 2 weeks before
the enrollment
5.Patients with FEV1<=50% predicted
6.Patients using beta blocker including
eye drops
7.Patients who have taken systemic
steroid within 30 days before the
enrollment
8.Patients with clinically severe
complication
9.Planning-to-be-pregnant, pregnant or
lactating patients
10.Any other conditions which in the
judgement of the investigator would
make the patient inappropriate for
study participation
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Takanashi
Organization Hirosaki University
Division name Health Administration Center
Zip code
Address 1-Bunkyocho Hirosaki-shi Aomori-ken, 036-8560, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Hayashi
Organization Hirosaki University Hspital
Division name Cardiology Respiratory Medicine and Nephrology
Zip code
Address 53-Honcho Hirosaki-shi Aomori-ken, 036-8563, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hirosaki University
Institute
Department

Funding Source
Organization Hirosaki University
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
2011 Year 10 Month 17 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
2011 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
2011 Year 10 Month 17 Day
Last modified on
2011 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007545

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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