UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Step down of inhaler therapy in well controlled asthmatics with ICS/LABA, Symbicort Turbuhaler.
Title of the study (Brief title)	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	Hirotsugu Kohrogi
Organization	Kumamoto University Hospital
Division name	Respiratory Medicine
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	Kazuhiko Fujii
Organization	Kumamoto University Hospital
Division name	Respiratory Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 05 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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