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Concomitant treatment with nebulized formoterol fumarate & tio-significant improvements -- COPD
Date:5/20/2008

andomization, subjects entered a six-week treatment period to evaluate the safety and efficacy of formoterol fumarate inhalation solution (FFIS; Perforomist, 20 g/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV1 over three hours (FEV1 AUC0-3) at the last visit (week 6).

The standardized absolute AUC0-3 for FEV1 following the first dose of study medication at Day 1 was statistically significantly improved in the Perforomist/TIO group compared with placebo/TIO group (PLA/TIO). FEV1 AUC0-3 remained significantly greater in the Perforomist/TIO group after six weeks without any decrease of effect or evidence of tolerance (p< 0.0001). Peak FEV1 levels were significantly higher in the Perforomist/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/TIO group compared with PLA/TIO. Use of albuterol rescue medication declined in the Perforomist/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. Georges 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/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 (formoterol fumarate) Inhalation Solution, the first and only FDA-approved nebulized formoterol fumarate, were also recently published. Perforomist Inhalation Solution is indicated
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Contact: Amy Techtmann
amy.techtmann@fkhealth.com
617-761-6784
Feinstein Kean Healthcare
Source:Eurekalert

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