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Clinical Trial Data on the Safety and Efficacy of Concomitant Formoterol Fumarate/ Tiotropium Treatment for COPD
Date:10/24/2007

-Data from Phase IIIb clinical study presented at CHEST 2007 on concomitant

use of Perforomist(TM) Inhalation Solution with tiotropium for COPD

treatment-

NAPA, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Data presented today at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), demonstrate concomitant use of nebulized formoterol fumarate and tiotropium provided improved bronchodilation over tiotropium monotherapy and was well-tolerated in this clinical study. The only commercially available version of nebulized formoterol fumarate is Perforomist(TM) Inhalation Solution, which is indicated for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol fumarate is a rapid and long-acting beta2-agonist (LABA) that has been previously available in the U.S. in a dry powder formulation and has twenty years of worldwide experience. Perforomist(TM) Inhalation Solution is the first and only FDA-approved nebulized form of this molecule. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

Results presented were from "Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD," a randomized, placebo-controlled Phase IIIb trial. The trial demonstrated that concomitant therapy with twice-daily nebulized formoterol fumarate (FFIS) and once-daily tiotropium provided patients with statistically significant and clinically relevant improvements in bronchodilation over treatment with tiotropium alone. In this six-week study, patients receiving concomitant therapy with nebulized FFIS and tiotropium experienced fewer adverse events or COPD exacerbations than patients receiving placebo or tiotropium monotherapy.

According to Donald P. Tashkin, MD, FACP, FCCP, Professor of Medi
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SOURCE Dey, L.P.
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