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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008948
Receipt No. R000010494
Scientific Title Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial -
Date of disclosure of the study information 2012/09/20
Last modified on 2016/12/14

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Basic information
Public title Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial -
Acronym SFC step-down study
Scientific Title Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial -
Scientific Title:Acronym 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6) Proportion of subjects withdrawn from the study (at Weeks 8 and 16)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
1st name
Middle name
Last name Soichiro Hozawa
Organization Hiroshima Allergy & Respiratory Clinic
Division name Internal, allergic and respiratory medicine
Zip code
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
1st name
Middle name
Last name Soichiro Hozawa
Organization Hiroshima Allergy & Respiratory Clinic
Division name Internal, allergic and respiratory medicine
Zip code
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)

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 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

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
2012 Year 08 Month 20 Day
Date of IRB
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

Other
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

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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