Conditions: Asthma
Keywords: FP/SLM Asthma Infant Efficacy Safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks.

The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (\<2 or \>=2 year-old) at Visit 1 and randomized to one of the two treatment groups.

The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.

Detailed description:

Arms:
arm 1: Subject will receive 1 or 2 inhalation of SLM 25mcg plus FP 50mcg twice daily in the first treatment period for 8 weeks and will continue to receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period. arm 2: Subject will receive 1 or 2 inhalation of FP 50mcg twice daily in the first treatment period for 8 weeks and will receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period.

Interventions: intervention 1: FP/ SLM HFA MDI 50/25 mcg intervention 2: FP HFA MDI 50 mcg
Intervention descriptions: intervention 1: Metered-dose aerosol product containing 50 mcg of fluticasone propionate and 25 mcg of salmeterol per inhalation intervention 2: Metered-dose aerosol product containing 50 mcg of fluticasone propionate per inhalation

Protocol document: