The FDA approval is based on two pivotal (Phase III) efficacy and safety trials, SHINE and SUN, which evaluated more than 3,600 patients ages 40 years and older with moderate to very severe COPD. (2) These studies demonstrated that patients using SYMBICORT pMDI 160/4.5 mcg had significantly greater mean improvements from baseline in pre-dose forced expiratory volume in one second (FEV1) averaged over the treatment period compared with formoterol 4.5 mcg and placebo.(2)
In addition, patients using SYMBICORT had significantly greater mean improvements from baseline in 1-hour post-dose FEV1 averaged over the treatment period compared with budesonide 160 mcg and placebo.(2) Furthermore, the median time to onset of significant bronchodilation (greater than or equal to 15% improvement in FEV1) was five minutes.(1)
SYMBICORT was generally well-tolerated over the 12-month study,(2) and the incidence of pneumonia was no different for SYMBICORT compared to placebo.(2) There was a higher incidence of potential lung infections other than pneumonia (e.g., bronchitis and viral lower respiratory tract infections) in patients receiving SYMBICORT 160/4.5 mcg than in those receiving formoterol 4.5 mcg or placebo.(2) The most common drug-related adverse events reported were nasopharyngitis (the common cold), oral candidiasis, bronchitis, sinusitis and viral upper respiratory tract infection.(2)
"Through these pivotal studies, SYMBICORT demonstrated rapid and sustained improvements in lung function and was generally well-tolerated long-term for patients with moderate to severe COPD,"(2) said lead investigator Dr. Donald Tashkin of the
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