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

oterol fumarate) Inhalation Solution, the first and only FDA-approved nebulized formoterol fumarate, were also recently published. Perforomist(TM) Inhalation Solution is indicated for long-term, twice-daily maintenance treatment of COPD.

-- "Efficacy and Safety of Formoterol Fumarate Delivered by Nebulization

to COPD Patients," published in the February 2008 issue of Respiratory

Medicine, detailed pivotal Phase III data that supported the NDA

approval for Perforomist(TM) (formoterol fumarate) Inhalation Solution.

The study demonstrated that Perforomist(TM) Inhalation Solution has a

rapid onset of significant bronchodilation within five minutes of

administration and is safe and effective. The study assessed the

efficacy and safety of Perforomist(TM) Inhalation Solution in 351

adults with moderate-to-severe COPD. Nicholas J. Gross, MD, PhD, Hines

VA Hospital, Stricht Loyola School of Medicine, was lead author and

principal investigator of the study.

-- In October 2007, Clinical Therapeutics published cardiac safety results

from the Phase III trial for Perforomist(TM) Inhalation Solution. In

"Cardiac Safety Profile of Nebulized Formoterol in Adults with COPD: A

12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-

and Active-Controlled Trial," the data showed that Perforomist(TM)

Inhalation Solution was associated with rapid and sustained improvement

in pulmonary function with no clinically significant cardiac effects,

including QT prolongation, increased proarrhythmic events, or changes

in serum potassium levels. Harold S. Nelson, MD, Professor of

Medicine, National Jewish Medical and Research Center; was lead author

of the article and principal investigator of the study. Patients with

cardiac problems were excluded from the study. Perforom
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SOURCE Dey, L.P.
Copyright©2008 PR Newswire.
All rights reserved

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