A 12-month, multi-center, randomized, double-blind, parallel-group, study compared FORADIL AEROLIZER 12 mcg twice daily and FORADIL AEROLIZER 24 mcg twice daily to placebo in a total of 518 children with asthma (ages 5-12 years) who required daily bronchodilators and anti-inflammatory treatment. Efficacy was evaluated on the first day of treatment, at Week 12, and at the end of treatment.

FORADIL AEROLIZER 12 mcg twice daily demonstrated a greater 12-hour FEV₁ AUC compared to placebo on the first day of treatment, after twelve weeks of treatment, and after one year of treatment. FORADIL AEROLIZER 24 mcg twice daily did not result in any additional improvement in 12-hour FEV₁ AUC compared to FORADIL AEROLIZER 12 mcg twice daily.

Exercise-Induced Bronchospasm Trials

The effect of FORADIL AEROLIZER on exercise-induced bronchospasm (defined as > 20% fall in FEV₁) was examined in four randomized, single-dose, double-blind, crossover studies in a total of 77 patients 4 to 41 years of age with exercise-induced bronchospasm. Exercise challenge testing was conducted 15 minutes, and 4, 8, and 12 hours following administration of a single dose of study drug (FORADIL AEROLIZER 12 mcg, albuterol 180 mcg by metered-dose inhaler, or placebo) on separate test days. FORADIL AEROLIZER 12 mcg and albuterol 180 mcg were each superior to placebo for FEV₁ measurements obtained 15 minutes after study drug administration. FORADIL AEROLIZER 12 mcg maintained superiority over placebo at 4, 8, and 12 hours after administration. Most subjects were protected from exercise-induced bronchospasm for up to 12 hours following administration of FORADIL AEROLIZER;however, some were not. The efficacy of FORADIL AEROLIZER in the prevention of exercise-induced bronchospasm when dosed on a regular twice daily regimen has not been studied.

Adult COPD Trials

In multiple-dose clinical trials in patients with COPD, FORADIL AEROLIZER 12 mcg was shown to provide onset of significant bronchodilation (defined as 15% or greater increase from baseline in FEV₁) within 5 minutes of oral inhalation after the first dose. Bronchodilation was maintained for at least 12 hours.

FORADIL AEROLIZER was studied in two pivotal, double-blind, placebo-controlled, randomized, multi-center, parallel-group trials in a total of 1634 adult patients (age range: 34-88 years; mean age: 63 years) with COPD who had a mean FEV₁ that was 46% of predicted. The diagnosis of COPD was based upon a prior clinical diagnosis of COPD, a smoking history (greater than 10 pack-years), age (at least 40 years), spirometry results (pre bronchodilator baseline FEV₁ less than 70% of the predicted value, and at least 0. 75 liters, with the FEV₁/VC being less than 88% for men and less than 89% for women), and symptom score (greater than zero on at least four of the seven days prior to randomization). These studies included approximately equal numbers of patients with and without baseline bronchodilator reversibility, defined as a 15% or greater increase FEV₁ after inhalation of 200 mcg of albuterol sulfate. A total of 405 patients received FORADIL AEROLIZER 12 mcg, administered twice daily. Each trial compared FORADIL AEROLIZER 12 mcg twice daily and FORADIL AEROLIZER 24 mcg twice daily with placebo and an active control drug. The active control drug was ipratropium bromide in COPD Trial A, and slow-release theophylline in COPD Trial B (the theophylline arm in this study was open-label). The treatment period was 12 weeks in COPD Trial A, and 12 months in COPD Trial B.

The results showed that FORADIL AEROLIZER 12 mcg twice daily resulted in significantly greater post-dose bronchodilation (as measured by serial FEV₁ for 12 hours post-dose; the primary efficacy analysis) compared to placebo when evaluated after 12 weeks of treatment in both trials, and after 12 months of treatment in the 12-month trial (COPD Trial B). Compared to FORADIL AEROLIZER 12 mcg twice daily, FORADIL AEROLIZER 24 mcg twice daily did not provide any additional benefit on a variety of endpoints including FEV₁.

Mean FEV₁ measurements after 12 weeks of treatment for one of the two major efficacy studies are shown in the figure below.

Figure 3: Mean FEV₁ after 12 Weeks of treatment from COPD Trial A

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