Unique ID issued by UMIN | UMIN000006553 |
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Receipt number | 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 15:02:23 |
Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Self-controlled, multicenter study for effects of Budesonide/Formoterol combination 8weeks therapy on peripheral blood eosinophils in patients with bronchial asthma.
Japan |
Bronchial asthma
Pneumology |
Others
NO
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.
Efficacy
Change in peripheral blood eosinophils
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Budesonide/Formoterol 160/4.5mcg, two inhalations, twice a day, 8 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Shingo Takanashi |
Hirosaki University
Health Administration Center
1-Bunkyocho Hirosaki-shi Aomori-ken, 036-8560, Japan
1st name | |
Middle name | |
Last name | Akihito Hayashi |
Hirosaki University Hspital
Cardiology Respiratory Medicine and Nephrology
53-Honcho Hirosaki-shi Aomori-ken, 036-8563, Japan
Hirosaki University
Hirosaki University
Self funding
NO
2011 | Year | 10 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 10 | Month | 17 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 17 | Day |
2011 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007545
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