Pediatric Patients with Asthma
The study enrolled 583 asthma patients, 4 to 11 years of age, although
the primary
efficacy parameter was evaluated only in the population of 513 patients 6 to 11 years of
age. In these patients, the mean FEV
1
at screening was 81.2%
predicted, and the mean
FEV
1
at baseline following a two week run-in period was 87.5% predicted. Patients were
randomized to AEROSPAN Inhalation Aerosol 80 mcg or 160
mcg twice daily,
flunisolide CFC inhalation aerosol 250 mcg or 500 mcg twice daily, or placebo. Change
from baseline
in percent predicted FEV
1
over 12 weeks in patients 6 years of age and
older demonstrated that placebo patients deteriorated 4.0% from baseline after 12 weeks
of
treatment, whereas patients treated with AEROSPAN Inhalation Aerosol 80 mcg or
160 mcg twice daily maintained FEV
1
over the course of the study.
Results for the
comparison to placebo were statistically significant for the 80 mcg and 160 mcg doses
doses of AEROSPAN Inhalation Aerosol, but there was no added benefit for the 160 mcg
BID dose over the 80 mcg BID dose (see Figure below). AEROSPAN Inhalation
Aerosol and flunisolide CFC inhalation aerosol gave comparable results in patients 6
years of age and older.
INDICATIONS AND USAGE
AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as
prophylactic therapy in adult and pediatric patients 6 years of age and older.
AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral
corticosteroid therapy, where adding AEROSPAN Inhalation
Aerosol may reduce or
eliminate the need for oral corticosteroids.
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