Aerospan tm (flunisolide hfa, 80 mcg) Inhalation Aerosol For Oral Inhalation Only Rx Only description

 
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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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