The first study was a single-dose, double-blind, double-dummy crossover dose-ranging study conducted in 47 patients to establish the dose of Perforomist(TM) Inhalation Solution comparable to that of the marketed DPI, Foradil(R) Aerolizer(R). Mean FEV(1) AUC(0-12) (standardized area under the curve for FEV(1) over twelve hours) following FFIS treatment ranged from 1.3 to 3.0 L/hr in a dose-related manner, with identical values (2.3 L/hr) for Perforomist(TM) Inhalation Solution 20mcg and Foradil(R) Aerolizer(R). All other spirometry measures were comparable between FFIS and FA.
The second study involving thirteen COPD patients was a randomized, single-dose, open-label, crossover study comparing FFIS 10, 20, and 24mcg with Foradil(R) Aerolizer(R), which confirmed pharmacokinetic comparability between Perforomist(TM) Inhalation Solution 20mcg by nebulization and Foradil(R) Aerolizer(R) 12mcg (Foradil) by DPI.
"This research continues to support and highlight the clinical value of
Perforomist(TM) Inhalation Solution," said Carolyn Myers, Ph.D., President
of Dey, L.P. "We thank all of these eminent researchers for their
contributions to the trials that were presented today and we remain
dedicated to developing nebulized treatment options for those suffering
from serious respiratory illnesses such as COPD."
For those attending ATS 2008, the presentations are available as follows:
Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of
Tuesday, May 20, 2008, 10:45 a.m. - 12:30 p.m. EDT
Metro Toronto Convention Center; Area F: Halls A-B North Building, Level
-- Poster #F13: Dose-Ranging Study in COPD Patients Comparing
Pharmacodynamics of Formoterol Fumarate Delivered by Nebulization and
-- Poster #F
|SOURCE Dey L.P.|
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