UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005780 |
|---|---|
| Receipt number | R000006787 |
| Scientific Title | Step down of inhaler therapy in well controlled asthmatics with ICS/LABA, Symbicort Turbuhaler. |
| Date of disclosure of the study information | 2011/06/14 |
| Last modified on | 2017/05/09 23:19:52 |
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Basic information
Public title
Step down of inhaler therapy in well controlled asthmatics with ICS/LABA, Symbicort Turbuhaler.
Acronym
Step Down Study
Scientific Title
Step down of inhaler therapy in well controlled asthmatics with ICS/LABA, Symbicort Turbuhaler.
Scientific Title:Acronym
Step Down Study
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the asthmatics who are well controlled by the treatment with combination of medium dose of inhaled glucocorticoid (ICS) combined with inhaled long acting beta-2 agonist (LABA), we ask which step down therapy is better, 1) continuation of medium dose of ICS without LABA, or 2) half dose of the combination of ICS and LABA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ACQ-5 (asthma control Questionnaire-5) 12 week after step down therapy
Key secondary outcomes
number of puffs in short acting beta2-agonist use
pulmonary function
PEFR
Exhaled nitric oxide
withdrawal due to exacerbation and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhalation of low-dose of budesonide / formoterol combination (Symbicort turbuhaler, one inhalatiom twice daily)
Interventions/Control_2
Inhalation of medium-dose of budesonide (Pulmicort 200 turbuhaler, two inhalatiom twice daily)
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
Well-controlled asthmatics with inhalation of medium-dose of budesonide / formoterol combination (Symbicort turbuhaler two inhalatiom twice daily) for twelve weeks
Key exclusion criteria
History of hypersensitivity to budesonide or formoterol
Use of systemic corticosteroids or anti-IgE antibody
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Kohrogi |
Organization
Kumamoto University Hospital
Division name
Respiratory Medicine
Zip code
Address
1-1-1, Honjo, Kumamoto city, Kumamoto, 860-8556 Japan
TEL
096-373-5012
kokyukinaika@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Fujii |
Organization
Kumamoto University Hospital
Division name
Respiratory Medicine
Zip code
Address
1-1-1, Honjo, Kumamoto city, Kumamoto, 860-8556 Japan
TEL
096-373-5012
Homepage URL
kokyukinaika@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
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
熊本大学医学部附属病院（熊本県）
熊本中央病院（熊本県） 熊本市民病院（熊本県）
熊本赤十字病院（熊本県） 熊本地域医療センター（熊本県）
熊本医療センター（熊本県） NTT西日本九州病院（熊本県）
熊本再春荘病院（熊本県） 山鹿市民医療センター（熊本県）
公立玉名中央病院（熊本県） 熊本南病院（熊本県）
球磨郡公立多良木病院（熊本県） 人吉総合病院（熊本県）
水俣総合医療センター（熊本県） 熊本労災病院（熊本県）
八代総合病院（熊本県） 上天草総合病院（熊本県）
大牟田天領病院（福岡県） 県立延岡病院（宮崎県）
済生会熊本病院（熊本県）
本庄内科病院（熊本県） 朝日野総合病院（熊本県）
たまのい内科クリニック（熊本県） 前田内科医院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 14 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006787
