{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["16"],"submitter":["Holz O"],"pubmed_abstract":["Background
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.Methods
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 afte"],"journal":["BMC pharmacology & toxicology"],"pagination":["21"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4533952"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial."],"pmcid":["PMC4533952"],"pubmed_authors":["Hanrahan J","Rosano M","Biller H","Mueller M","Hava DL","Holz O","Hohlfeld JM","Kane K"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial.","description":"Background
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.Methods
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 afte","dates":{"release":"2015-01-01T00:00:00Z","publication":"2015 Aug","modification":"2026-06-14T09:48:38.405Z","creation":"2019-03-27T01:56:39Z"},"accession":"S-EPMC4533952","cross_references":{"pubmed":["26265479"],"doi":["10.1186/s40360-015-0021-1"]}}