biostudies-literatureUnknown16Holz O<h4>Background</h4>The ozone challenge model can be used to assess the efficacy of anti-inflammatory compounds in early phases of clinical drug development. PUR118, a calcium salt based formulation engineered in the iSPERSE(TM) dry powder delivery technology, is a novel anti-inflammatory drug for COPD. Here we evaluated the efficacy and safety of three doses of PUR118 in attenuating ozone-induced airway inflammation in healthy volunteers.<h4>Methods</h4>In a single-blind, phase 1B proof of concept study, 24 subjects were enrolled to sequentially receive three doses of PUR118 (5.5 mg, n = 18; 11.0 mg, n = 18; 2.8 mg, n = 16). Each dose was inhaled 3 times (1, 13, 25 h, preceded by 2 puffs salbutamol) before the ozone exposure (250 ppb, 3 h intermittent exercise). Sputum was induced 3 h afteBMC pharmacology & toxicology21https://www.ebi.ac.uk/biostudies/studies/S-EPMC4533952biostudies-literatureEfficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial.PMC4533952Hanrahan JRosano MBiller HMueller MHava DLHolz OHohlfeld JMKane KfalseEfficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial.<h4>Background</h4>The ozone challenge model can be used to assess the efficacy of anti-inflammatory compounds in early phases of clinical drug development. PUR118, a calcium salt based formulation engineered in the iSPERSE(TM) dry powder delivery technology, is a novel anti-inflammatory drug for COPD. Here we evaluated the efficacy and safety of three doses of PUR118 in attenuating ozone-induced airway inflammation in healthy volunteers.<h4>Methods</h4>In a single-blind, phase 1B proof of concept study, 24 subjects were enrolled to sequentially receive three doses of PUR118 (5.5 mg, n = 18; 11.0 mg, n = 18; 2.8 mg, n = 16). Each dose was inhaled 3 times (1, 13, 25 h, preceded by 2 puffs salbutamol) before the ozone exposure (250 ppb, 3 h intermittent exercise). Sputum was induced 3 h afte2015-01-01T00:00:00Z2015 Aug2026-06-14T09:48:38.405Z2019-03-27T01:56:39ZS-EPMC45339522626547910.1186/s40360-015-0021-1