Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults...(CLA). Data from these trials also showe...),Health

SHINE Study Results (Abstracts 298 and SHINE Safety)

The efficacy and tolerability of SYMBICORT was assessed in a six-month, randomized, double-blind, multicenter trial evaluating 1,704 patients ages 40 years and older with moderate to very severe COPD.(1,2) After two weeks of treatment based on previous therapy (inhaled corticosteroids (ICS) and short-acting bronchodilators were allowed), patients were then randomized to receive twice-daily treatment with two inhalations of SYMBICORT pMDI 160/4.5 micrograms (mcg), SYMBICORT pMDI 80/4.5 mcg, budesonide pMDI 160 mcg + formoterol DPI 4.5 mcg, budesonide pMDI 160 mcg, formoterol DPI 4.5 mcg or placebo.(1,2) Study results include:

-- Both SYMBICORT doses (160/4.5 and 80/4.5 mcg) demonstrated a significantly greater improvement from baseline in pre-dose forced expiratory volume in one second (FEV1) (P Less Than or Equal To .001) and one-hour post-dose FEV1 compared with budesonide (P<.001).(1)

-- SYMBICORT 160/4.5 mcg also demonstrated a significant (P=.026) improvement from baseline for pre-dose FEV1 compared with formoterol.(1)

-- Improvements from baseline in morning and evening peak expiratory flow (PEF) were significantly (P Less Than or Equal To .016) greater for both SYMBICORT doses compared with formoterol, budesonide and placebo.(1)

-- Both SYMBICORT doses significantly (P<.028) improved the sum of Breathlessness, Cough and Sputum Scores (BCSS), sleep score, awakening-free nights, and rescue medication use versus placebo.(1)

-- Both doses of SYMBICORT were well-tolerated for six months relative to its monocomponents and placebo.(2) The incidence of pneumonia-related adverse events were similar for all treatment arms compa
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