AZ presents SHINE/SUN data at CHEST 2008

Anglo-Swedish drug major AstraZeneca presented data from the pivotal SHINE and SUN trials of its asthma treatment Symbicort (budesonide/formoterol fumarate dihydrate) in patients with chronic obstructive pulmonary disease at the CHEST 2008 international scientific assembly of the American College of Chest Physicians in Philadelphia.

The six-month, randomized, double-blind, multicenter SHINE trial evaluated 1,704 patients aged 40 years and older with moderate-to-very-severe COPD. Patients were randomized to receive twice-daily treatment with two inhalations of Symbicort 160/4.5mcg or 80/4.5mcg, budesonide 160mcg plus formoterol 4.5mcg, budesonide 160mcg, formoterol 4.5mcg or placebo. Both Symbicort doses demonstrated a significantly-greater improvement from baseline in pre-dose forced expiratory volume in one second (p less than or equal to 0.001) compared with budesonide (p<0.001) and formoterol (p=0.026).

The 12-month, randomized, double-blind, multicenter SUN study evaluated 1,964 patients, again aged 40 years and older with moderate-to-very-severe COPD. Patients were then randomized to receive twice-daily treatment with two inhalations of Symbicort 160/4.5mcg, Symbicort 80/4.5mcg, formoterol 4.5mcg or placebo. Symbicort 160/4.5mcg demonstrated significantly-greater (p less than or equal to 0.023) improvements from baseline in pre-dose FEV1 and one-hour post-dose FEV1 compared with formoterol. Exacerbation rates were significantly (p less than or equal to 0.004) reduced by around 25% to 30% with both doses of Symbicort compared to formoterol and by approximately 40% compared to placebo.