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Perforomist Inhalation Solution data to be presented today at American Thoracic Society conference
Date:5/19/2009

dyspnea and rescue medication use were seen over tiotropium treatment alone, without any additional safety or tolerability issues.

Efficacy was measured by serial spirometry, transitional dyspnea index (TDI), rescue albuterol use and the St. George's Respiratory Questionnaire (SGRQ).

The primary efficacy endpoint was standardized absolute FEV1 AUC0-3. At Week 6 the primary efficacy endpoint was significantly improved by 192 mL compared with placebo/tiotropium (1.54 versus 1.37 L, p<0.0001). Following treatment, the mean TDI score showed a significant and clinically meaningful improvement in dyspnea in the Perforomist Inhalation Solution/tiotropium group compared with the placebo/tiotropium group, with mean TDI scores of 1.97 and 0.67, respectively (p=0.0001).

When Perforomist Inhalation Solution was added to tiotropium there was a significant decrease in the need for rescue albuterol use throughout the double-blind period compared with placebo/tiotropium (p<0.0001). SGRQ scores were similar both between treatments and to baseline, except the symptom domain score, which fell in the Perforomist Inhalation Solution/tiotropium group (-5.8) compared with placebo/tiotropium group (-1.0).

Overall, 31 percent of Perforomist Inhalation Solution/tiotropium-treated subjects experienced adverse events versus 46 percent of the placebo/tiotropium-treated subjects. COPD exacerbations were the most common adverse events, and occurred in over twice as many placebo/tiotropium-treated subjects as Perforomist Inhalation Solution/tiotropium-treated subjects. The most frequent adverse events following COPD exacerbations were acute bronchitis and upper respiratory tract infections.

"COPD patients in this analysis saw improvement in several areas when adding Perforomist Inhalation Solution to their tiotropium treatment," said Davida J. White Pettaway, M.D., Senior Manager, Medical and Scientific Affairs, Dey, L.P. "Having replicate
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Contact: Julie Piszczor
jpiszczor@powelltate.com
202-585-2106
Powell Tate
Source:Eurekalert

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