UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006572 |
|---|---|
| Receipt number | 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 15:18:46 |
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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
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
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007747
