Asthma Clinical Trial
Official title:
Clinical Assessment of Fluticasone Propionate/ Salmeterol Xinafoate HFA MDI in 6-month to 4-year-old Japanese Patients With Bronchial Asthma
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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