UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial -
Title of the study (Brief title)	SFC step-down study
Region	Japan

Condition
Condition	Bronchial Asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Adult patients aged 15 years or older who have well-controlled asthma with SFC250 twice daily will be stepped down to SFC100 or FP200, both twice daily and the effects of these two treatments on the maintenance rate of asthma control and airway inflammation will be compared after 16 weeks based on asthma control test (ACT), Leicester cough questionnaire(LCQ),peak expiratory flow (PEF),forced expiratory volume in one second (FEV1) and fractional exhaled nitric oxide (FeNO).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Morning PEF [change from baseline (mean of 7-day measurements before treatment) at Weeks 8 and 16]
Key secondary outcomes	1) ACT (change from baseline in the proportion of well-controlled patients at Weeks 8 and 16) 2) LCQ (change from baseline at Weeks 8 and 16) 3) Morning and evening PEF (change from baseline at Weeks 8 and 16) 4) Asthma symptom score, the number of nighttime awakenings and the number of rescue medication use. 5) FEV1, PEF, MMEF, V50, V25 (change from baseline in score at Weeks 8 and 16) 6) Proportion of subjects withdrawn from the study (at Weeks 8 and 16)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FP200
Interventions/Control_2	SFC100
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	At 8 weeks before the start of study treatment: 1) Males or females aged >=15 years 2) Airway reversibility >=12% and >=200mL in year past. 3) Well-controlled asthma (ACT score>=20) with SFC125 aerosol 2 puffs bid for at least 8 weeks 4) A history of exacerbation of asthma* within one year 5) Able to give informed consent to participate in the study *Exacerbation of asthma: requiring oral steroids, emergency visits or hospitalization At the start of study treatment 1) Well-controlled asthma (ACT score >= 20 at 4weeks before the study treatment and 0week ) with SFC125 aerosol 2 puffs bid for at least 8 weeks 2) Not using inhaled steroids or long acting B2-agonists other than SFC125 aerosol
Key exclusion criteria	1)A history of exacerbation of asthma within 8 weeks before randomization 2) Other respiratory diseases [e.g., chronic obstructive pulmonary disease (COPD), etc.], rhinitis or sinusitis 3) Smokers at registration in 1 year 4) Is pregnant, lactating or is of childbearing potential and is likely to become pregnant 5) Unsuitable for the study (e.g., other severe disorders, etc.) in the judgment of the investigator/sub-investigator
Target sample size	200

Research contact person
Name of lead principal investigator	Soichiro Hozawa
Organization	Hiroshima Allergy & Respiratory Clinic
Division name	Internal, allergic and respiratory medicine
Address	Daiichi Teraoka building 6F, 1-9-28, Hikari-machi, Higashi-ku, Hiroshima-city, 732-0052, Japan
TEL	082-568-1167
Email	hozawa@vesta.ocn.ne.jp

Public contact
Name of contact person	Soichiro Hozawa
Organization	Hiroshima Allergy & Respiratory Clinic
Division name	Internal, allergic and respiratory medicine
Address	Daiichi Teraoka building 6F, 1-9-28, Hikari-machi, Higashi-ku, Hiroshima-city, 732-0052, Japan
TEL	082-568-1167
Homepage URL
Email	hozawa@vesta.ocn.ne.jp

Sponsor
Institute	SFC Stepdown Study Group
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
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	広島アレルギー呼吸器クリニック（広島県）、いけだ内科（山口県）、大道内科・呼吸器科クリニック（北海道）、亀井内科呼吸器科医院（香川県）、山田記念病院（広島県）、下山記念クリニック（広島県）、坂出市立病院（香川県）、KKR高松病院（香川県）、なかの呼吸器内科クリニック（北海道）、おびひろ呼吸器科内科病院（北海道）、医大前南4条内科（北海道）、牧田病院（北海道）、おたる内科呼吸器科（北海道）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 20 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 20 Day
Last modified on	2016 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010494