Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.

Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid. - Usefulness of salmeterol/fluticasone combination (SFC) therapy in preschool children with uncontrolled asthma treated with inhaled corticosteroid.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006770

Enrollment

Registered

2011-11-25

Start date

2011-12-01

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

Preschool children with asthma

Interventions

Fluticasone propionate 50mcg aerosol, 2puff twice daily, for 4weeks to 8weeks. Or beclomethasone dipropionate 50mcg aerosol, 1puff twice daily, for 4weeks to 8weeks. Or ciclesonide 100mcg inhaler, 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Preschool childhood asthma aged 6 months to 5 years. Gender does not matter. 2)A signed and dated written informed consent is obtained prior to participation from the parent.

Exclusion criteria

Exclusion criteria: 1)Patients already treated with SFC. 2)Use inhaled, patch, and oral bronchodilator as long-term management (controller). 3)Patients have hypersensitivity to salmeterol or fluticasone propionate, or suspected patient. 4)The patients who are inappropriate considered by physician.

Design outcomes

Primary

Measure	Time frame
Nighttime awakening	—

Secondary

Measure	Time frame
Asthma symptom score Asthma control questionnaire for preschool child QOL questionnaire for parent Number of SABA use Number of unscheduled Doctor visit Frequency of exacerbations with viral infection	—

Countries

Japan

Contacts

Public ContactShigemi Yoshihara

Dokkyo Medical University Department of Pediatrics

Outcome results

None listed

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