UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Title of the study (Brief title)	Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Region	Japan

Condition
Condition	bronchial asthma
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement ratio (%) for the health outcome (degree of suffering and trouble; VAS value) by BUD/FM
Key secondary outcomes	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

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Budesonide160mcg/Formoterol4.5mcg once 2 inhalation,b.i.d.
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	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
Key exclusion criteria	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
Target sample size	30

Research contact person
Name of lead principal investigator	Hozawa Soichiro
Organization	Hiroshima Allergy and Pulmonary Clinic
Division name	Department of allergy
Address	1-9-28 Hikari-machi, Higashi-Ku, Hiroshima-city , Hiroshima, Japan
TEL	082-568-1167
Email	hozawa@vesta.ocn.ne.jp

Public contact
Name of contact person	Hozawa Soichiro
Organization	Hiroshima Allergy and Pulmonary Clinic
Division name	Department of allergy
Address	1-9-28 Hikari-machi, Higashi-Ku, Hiroshima-city , Hiroshima, Japan
TEL	082-568-1167
Homepage URL
Email	hozawa@vesta.ocn.ne.jp

Sponsor
Institute	Hiroshima Allergy and Pulmonary Clinic
Institute
Department

Funding Source
Organization	Hiroshima Allergy and Pulmonary Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)

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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 30 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 01 Day
Last modified on	2017 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032606