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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028486
Receipt No. 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

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Basic information
Public title Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Acronym Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Scientific Title Clinical evaluation In the health outcome of patients with bronchial asthma at the first visit and unscheduled visit with budesonide/formoterol therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Hozawa Soichiro
Organization Hiroshima Allergy and Pulmonary Clinic
Division name Department of allergy
Zip code
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
1st name
Middle name
Last name Hozawa Soichiro
Organization Hiroshima Allergy and Pulmonary Clinic
Division name Department of allergy
Zip code
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)

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
2017 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 30 Day
Date of IRB
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

Other
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

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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