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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005780
Receipt No. 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

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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
Email 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
Email kokyukinaika@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006787

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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