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Landmark COPD Trial UPLIFT(R) Shows SPIRIVA(R) HandiHaler(R) Sustained Lung Function Improvements Over Four Years
Date:10/5/2008

Results published in New England Journal of Medicine reaffirm well-established efficacy and long-term safety profile of SPIRIVA(R) HandiHaler(R)

RIDGEFIELD, Conn., and NEW YORK, Oct. 5 /PRNewswire/ -- Results of the UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) trial, showed that SPIRIVA(R) HandiHaler(R) (tiotropium bromide inhalation powder), sustained improvements in lung function for up to 4 years as measured by FEV(1) (p<0.001) versus placebo in Chronic Obstructive Pulmonary Disease (COPD) patients. It did not significantly reduce the accelerated rate of decline in lung function, as measured by FEV(1), which was the primary endpoint of the study. The landmark study, published online today in the New England Journal of Medicine and presented at the European Respiratory Society (ERS) Annual Congress, also reaffirmed the well-established, long-term safety profile of SPIRIVA.

UPLIFT, one of the largest COPD trials ever undertaken, is a four-year multicenter (470 sites), multinational (37 countries), randomized, double-blind, placebo-controlled, parallel-group prospective trial. The study included 5993 male and female COPD patients. Patients were randomized 1:1 to receive either 18 micrograms tiotropium or placebo (control) once daily. In both arms, patients were allowed to use all other prescribed respiratory medications, except for inhaled anticholinergics.

Secondary Endpoints

UPLIFT showed that SPIRIVA produced a significant delay in time to first exacerbation by a median of 4.1 months (p<0.001) versus control, a significant reduction in the number of exacerbations per patient year (14 percent; p<0.001). In addition, it significantly reduced the risk of exacerbations leading to hospitalizations (Hazard Ratio 0.86; p<0.002) versus the control group. In the UPLIFT trial, a COPD exacerbation was defined as an increase or new onset of more than one of the following respiratory symptoms: cough, phlegm,
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer
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