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

CLINICAL TRIALS 
 
 
The efficacy of AEROSPAN Inhalation Aerosol has been studied in two double-blind, 
parallel, placebo-and active-controlled clinical studies of 12 weeks duration involving 
more than 1250 patients. In patients 12 to 78 years of age, efficacy was evaluated in 
patients previously treated with inhaled corticosteroids. In patients 6 to 11 years of age, 

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efficacy was evaluated in patients previously treated with bronchodilators alone or 
inhaled corticosteroids. Both studies had a 2-week run-in period followed by a 12-week 
randomized treatment period. During the run-in period all patients received flunisolide 
CFC inhalation aerosol 500 mcg twice daily. Patients were then randomized to double-
blind treatment with different doses of AEROSPAN Inhalation Aerosol or flunisolide 
CFC inhalation aerosol and monitored for lung function changes to see if they 
maintained, improved, or lost stability. Baseline was assessed at the end of the run-in 
period. The primary endpoint was the change from baseline in percent predicted FEV
1
after 12 weeks treatment. 
Adult and Adolescent Patients with Asthma 
 
Efficacy was evaluated in 669 asthma patients, age 12 to 78 years of age, including 88 
patients 12-17 years of age and 581 patients 18 years and older. Mean FEV
1
at screening 
was 2.44 L and mean FEV
1
at baseline was 2.72 L following the 2-week run-in period.
Patients were randomized to AEROSPAN Inhalation Aerosol 80 mcg, 160 mcg or 320 
mcg twice daily, flunisolide CFC inhalation aerosol 250 mcg, 500 mcg, or 1000 mcg 
twice daily, or placebo. Change from baseline in percent predicted FEV
1
over 12 weeks 
treatment demonstrated that placebo patients deteriorated 4.3% from baseline after 12 
weeks of treatment, whereas patients treated with AEROSPAN Inhalation Aerosol 160 
mcg or 320 mcg twice daily maintained FEV
1
over the course of the study. Results for 
the comparison to placebo were statistically significant for the 160 and 320 mcg twice 
daily AEROSPAN Inhalation Aerosol doses (see Figure below), but not for the 80 mcg 
dose. Secondary endpoints of AM peak expiratory flow rate, AM and PM asthma 
symptoms, nocturnal awakenings requiring a 
β
2
agonist, and as needed use of inhaled 
β
2
agonists showed differences from baseline favoring AEROSPAN Inhalation Aerosol over 
placebo. AEROSPAN Inhalation Aerosol and flunisolide CFC inhalation aerosol gave 
comparable results.