Concomitant use of Perforomist & tiotropium -- significant improvemen...( Napa CA (May 20 2008) Data presente...),Health

Napa, CA (May 20, 2008) Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that concomitant therapy with Perforomist Inhalation Solution (formoterol fumarate inhalation solution; FFIS), delivered by nebulization, and Spiriva (tiotropium; TIO) is significantly more effective than treatment with tiotropium alone.

Perforomist Inhalation Solution was approved in 2007 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.

Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles and lead clinical investigator, presented the results from Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in COPD Patients in a poster session today.

In this study there was a significant improvement in patients treated concomitantly with Perforomist nebulized formoterol fumarate and tiotropium over tiotropium alone, said Dr. Tashkin. These data provide physicians with a new and valuable treatment option for COPD patients with moderate to severe manifestations of the disease.

This randomized, placebo-controlled double-blind trial was conducted in 130 patients with moderate to severe COPD to evaluate the efficacy and safety of Perforomist, nebulized FFIS, when added to Spiriva maintenance treatment. Patient-centered outcomes were measured by the baseline/transitional dyspnea index, daily recording of COPD symptoms, rescue albuterol use and St. Georges Respiratory Questionnaire (SGRQ).

In this trial there was a statistical significance between the mean transitional dyspnea index scores in the Perforomist/TIO and TIO/placebo groups (2.30 and 0.16, respectively; p=0.0002).
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