Adult and Adolescent Patients 12 Years of Age and Older: In a 6-week, randomized, double-blind, placebo-controlled trial, Albuterol Sulfate Inhalation Aerosol (58 patients) was compared to a matched placebo HFA inhalation aerosol (58 patients) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol four times daily. An evaluator-blind marketed active comparator HFA-134a albuterol inhaler arm (56 patients) was included.

Serial FEV1 measurements, shown below as percent change from test-day baseline at Day 1 and at Day 43, demonstrated that two inhalations of Albuterol Sulfate Inhalation Aerosol produced significantly greater improvement in FEV1 over the pre-treatment value than the matched placebo, as well as a comparable bronchodilator effect to the marketed active comparator HFA-134a albuterol inhaler.

In this study, 31 of 58 patients treated with Albuterol Sulfate Inhalation Aerosol achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. In these patients, the median time to onset, median time to peak effect, and median duration of effect were 8.2 minutes, 47 minutes, and approximately 3 hours, respectively. In some patients, the duration of effect was as long as 6 hours.

In a placebo-controlled, single-dose, crossover study, Albuterol Sulfate Inhalation Aerosol, administered at albuterol doses of 90, 180 and 270 mcg, produced bronchodilator responses significantly greater than those observed with a matched placebo inhalation aerosol and comparable to a marketed active comparator HFA-134a albuterol inhaler.

Pediatric Patients 4 to 11 Years of Age: In a 3-week, randomized, double-blind, placebo-controlled trial, the same formulation of albuterol as in Albuterol Sulfate Inhalation Aerosol (50 patients) was compared to a matched placebo HFA inhalation aerosol (45 patients) in asthmatic children 4 to 11 years of age at a dose of 180 mcg albuterol four times daily. Serial FEV1 measurements, expressed as the maximum percent change from test-day baseline in percent predicted FEV1 at Day 1 and at Day 22 observed within two hours post-dose, demonstrated that two inhalations of HFA albuterol sulfate produced significantly greater improvement in FEV1 over the pre-treatment value than the matched placebo.

In this study, 21 of 50 pediatric patients treated with the same formulation of albuterol as in Albuterol Sulfate Inhalation Aerosol achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. In these patients, the median time to onset, median time to peak effect and median duration of effect were 10 minutes, 31 minutes, and approximately 4 hours, respectively. In some pediatric patients, the duration of effect was as long as 6 hours.

In a placebo-controlled, single-dose, crossover study in 55 pediatric patients 4 to 11 years of age, Albuterol Sulfate Inhalation Aerosol, administered at albuterol doses of 90 and 180 mcg, was compared with a matched placebo HFA inhalation aerosol. Serial FEV1 measurements, expressed as the baseline-adjusted percent predicted FEV1 observed over 6 hours post-dose, demonstrated that one and two inhalations of Albuterol Sulfate Inhalation Aerosol produced significantly greater bronchodilator responses than the matched placebo.