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8 Dec 2011

Pearl Therapeutics Announces Phase 2b Results of COPD Drug Trial

Pearl Therapeutics announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate.

Pearl Therapeutics Inc. announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist (LAMA) delivered twice a day (BID) via metered-dose inhaler (GP MDI; PT001) in patients with moderate-to-severe COPD.

 

Four doses of GP MDI were compared to placebo and Atrovent? HFA Inhalation Aerosol, a short-acting muscarinic antagonist given four times a day (QID). All doses of GP MDI tested produced statistically significant improvements in lung function (FEV1 AUC 0-12) compared to placebo (p<0.0001).

 

Further, doses of PT001 were identified that were non-inferior to Atrovent HFA. PT001 was well tolerated and no safety concerns were identified.

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