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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006572
Receipt No. R000007747
Scientific Title Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Date of disclosure of the study information 2011/10/18
Last modified on 2015/10/19

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Basic information
Public title Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Acronym Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Scientific Title Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Scientific Title:Acronym Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Region
Japan

Condition
Condition Patients with bronchial asthma aged 20 years and older (males and females, outpatients and inpatients) being treated with an ICS (at a dose equivalent to FP 200-1000 mcg/day) and salmeterol 100 mcg/day in combination (either as two separate products or one combined product) for 3 months or longer with poor or inadequate control
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improved effects of budesonide/formoterol on airway inflammation and respiratory resistance in patients with bronchial asthma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of various indicators
1)Fraction of exhaled Nitric Oxide
2)Mostgraph
3)Airway resistance of interrupter method
Key secondary outcomes Respiratory Function(FEV1)
Improvement of ACQ(asthma control questionnaire)score
Frequency of use of short-acting inhaled be-ta2 agonist(SABA)
Number of adverse event

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 160/4.5 mcg,2-4inhalations,twice a day
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)Aged>=20years old
2)Patients who has diagnosed as bronchial asthma
3)Patients who has provided written consent prior to enrollment
Key exclusion criteria 1)Patients with infections with no available effective antimicrobial drugs or with deep mycosis.
2)Patients with a history of hypersensitivity(including contact dermatitis)to any ingredient contained in budesonide/formoterol.
3)Patients with tuberculous disease
4)5)Case with the following complications
-Severe liver disease
-Severe renal disease
6)Planning-to-be-pregnant,pregnant or lactating patients
7)Patients who are inappropriate considered by physician.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Tanaka
Organization Chiba-Hokusoh Hospital, Nippon Medical School
Division name Department of Respiratory Medicine
Zip code
Address 1715 Kamagari, Inzai, Chiba, 270-1694, Japan
TEL 0476991961
Email yosuke-t@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Tanaka
Organization Chiba-Hokusoh Hospital, Nippon Medical School
Division name Department of Respiratory Medicine
Zip code
Address 1715 Kamagari, Inzai, Chiba, 270-1694, Japan
TEL 0476991961
Homepage URL
Email yosuke-t@nms.ac.jp

Sponsor
Institute Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department

Funding Source
Organization None
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 日本医科大学千葉北総病院呼吸器センター(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 18 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 Completed
Date of protocol fixation
2011 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 18 Day
Last modified on
2015 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007747

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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