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Pearl Therapeutics to Present Complete PT003 Results from Phase 2b COPD Study in a Late-Breaker Session at the American Thoracic Society Annual Meeting
Date:4/29/2011

is below and full abstracts will be available through the American Journal of Respiratory and Critical Care Medicine journal website beginning on May 2 at http://ajrccm.atsjournals.org.Presentation Date/Time: Wednesday, May 18, 2011 from 8:15am – 10:45amPoster Title: Pearl Therapeutics' combination LAMA/LABA MDI (GFF-MDI) provides superior bronchodilation compared to its components administered alone, tiotropium DPI, and formoterol DPI in a Randomized, Double-Blind, Placebo-Controlled Phase 2b StudyAbstract Number: 611 Session and Location: D30 , Room 403-404, Colorado Convention CenterIn December 2010, Pearl released top-line Phase 2b results   from this study, which demonstrated that PT003 provides superior bronchodilation compared to the current market leader, Spiriva, as well as to Foradil, placebo and PT003's individual components, Pearl's glycopyrrolate MDI (PT001; GP MDI) and formoterol MDI (PT005; FF MDI). The p-value for all comparisons was <0.0002. Additional data on primary and secondary endpoints will be presented at ATS.  

Phase 2b Study DesignThis Phase 2b study randomized 118 patients to one of the following study arms: high or low dose PT003 administered twice-daily (BID), high or low dose PT001, PT005, tiotropium bromide (Spiriva® Handihaler®), formoterol fumarate (Foradil® Aerolizer®) and placebo. Placebo, PT003, PT001 and PT005 were administered BID via HFA MDI for one week while Spiriva and Foradil were administered according to their approved label: 18 ug once daily (via Handihaler® inhaler) and 12 ug BID (via Aerolizer® inhaler), respectively, each for one week. The primary endpoint in this study was an improvement in lung function as assessed by FEV1 AUC0-12 (forced expiratory volume in one second)*, relative to baseline at the start of tr
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