UMIN-CTR Clinical Trial

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

Bronchial Asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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6) Proportion of subjects withdrawn from the study (at Weeks 8 and 16)

Study type

Interventional

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

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

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

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

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

Institute

SFC Stepdown Study Group

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

09

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

09

Month

20

Day

Last modified on

2016

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010494