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Concomitant Treatment With Nebulized Formoterol Fumarate and Tiotropium Provides Clinically Significant Improvements for COPD Patients
Date:5/20/2008

cts received once-daily treatment with tiotropium bromide inhalation powder (TIO; Spiriva(R), 18mcg) administered with a HandiHaler(R). Following randomization, subjects entered a six-week treatment period to evaluate the safety and efficacy of formoterol fumarate inhalation solution (FFIS; Perforomist(TM), 20mcg/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV(1) over three hours (FEV(1) AUC(0-3)) at the last visit (week 6).

The standardized absolute AUC(0-3) for FEV(1) following the first dose of study medication at Day 1 was statistically significantly improved in the Perforomist(TM)/TIO group compared with placebo/TIO group (PLA/TIO). FEV(1) AUC(0-3) remained significantly greater in the Perforomist(TM)/TIO group after six weeks without any decrease of effect or evidence of tolerance (p< 0.0001). Peak FEV(1) levels were significantly higher in the Perforomist(TM)/TIO group compared with PLA/TIO (p< 0.0001). Symptoms, including shortness of breath, chest tightness, night-time awakenings, and the total respiratory symptom score, were all significantly improved in the Perforomist(TM)/TIO group compared with PLA/TIO. Use of albuterol rescue medication declined in the Perforomist(TM)/TIO group and remained low throughout the treatment, whereas albuterol use in the PLA/TIO group trended higher through the six weeks of treatment (p<0.0001), suggesting enhanced control of COPD symptoms.

Quality of life was assessed with St. George's Respiratory Questionnaire (SGRQ), the results of which were similar at day 1 and did not change markedly over the six weeks of treatment. The only statistically significant and clinically relevant treatment difference observed with Perforomist(TM)/TIO compared with PLA/TIO was an improvement in symptom score (LS mean change of - 5.8 units).

Other Recently Published Data

Results from the Phase III pivotal trial of Perforomist(TM) (form
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SOURCE Dey, L.P.
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