Unique ID issued by UMIN | UMIN000028486 |
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Receipt number | R000032606 |
Scientific Title | Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy |
Date of disclosure of the study information | 2017/10/01 |
Last modified on | 2017/08/01 21:26:53 |
Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Japan |
bronchial asthma
Clinical immunology |
Others
NO
To clarify the health outcome (degree of suffering and trouble) and the patient's desire at the first visit and unscheduled visit as well as to evaluate the effect and safety of therapy of budesonide/formoterol (BUD/FM) for their health outcome
Efficacy
Improvement ratio (%) for the health outcome (degree of suffering and trouble; VAS value) by BUD/FM
Comparison of the followings between at the baseline and at 4 weeks;
-ACQ score
-FeNO
-Airway resistance with IOS
-%FEV1.0
-Frequency of SABA use
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Medicine |
Budesonide160mcg/Formoterol4.5mcg once 2 inhalation,b.i.d.
20 | years-old | <= |
Not applicable |
Male and Female
Patient who meet following criteria
1)Man or woman who is 20 years old or older at the time of getting informed consent
2)Patients diagnosed with asthma
3)Patient whose value of FeNO more than 40 ppb
Following are exclusion criteria
1)Patient with the drug allergy
2)Infection in the absence of effective antimicrobial agents,patients with deep mycosis
3)Patients with tuberculous disease,or respiratory infection
4)Patients with abnormal chest X-ray image
5)Patients with respiratory disease and other respiratory infections in 8 weeks before inclusion
6)Patients are using the b-blockers, including eye drops or patients with systemic corticosteroids to less than 30 days
7)Patients with serious complications
8)Smoking history of 10 pack years or more and with less than 6 months or by non smoking
9)Patients with pregnancy,or who hope for a pregnancy
10)Patients were deemed inappropriate research attending physician is incorporated into this study
30
1st name | |
Middle name | |
Last name | Hozawa Soichiro |
Hiroshima Allergy and Pulmonary Clinic
Department of allergy
1-9-28 Hikari-machi, Higashi-Ku, Hiroshima-city , Hiroshima, Japan
082-568-1167
hozawa@vesta.ocn.ne.jp
1st name | |
Middle name | |
Last name | Hozawa Soichiro |
Hiroshima Allergy and Pulmonary Clinic
Department of allergy
1-9-28 Hikari-machi, Higashi-Ku, Hiroshima-city , Hiroshima, Japan
082-568-1167
hozawa@vesta.ocn.ne.jp
Hiroshima Allergy and Pulmonary Clinic
Hiroshima Allergy and Pulmonary Clinic
Other
none
NO
2017 | Year | 10 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
2017 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032606
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