Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial -

Comparison between FP200 and SFC100 as Step-down Treatment from Well-Controlled Asthma Patients with SFC250 - Multicenter Trial - - SFC step-down study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008948

Enrollment

200

Registered

2012-09-20

Start date

2012-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

FP200 SFC100

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Morning PEF [change from baseline (mean of 7-day measurements before treatment) at Weeks 8 and 16]	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactSoichiro Hozawa

Hiroshima Allergy & Respiratory Clinic Internal, allergic and respiratory medicine

hozawa@vesta.ocn.ne.jp082-568-1167

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026