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Result Summaries: umeclidinium bromide

GSK
Study ID
   Phase    Title Summary (Download)
105209 phase 1 A randomized double-blind, placebo-controlled, crossover, dose escalation study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled doses of GSK233719 in healthy normal volunteers (single and repeat dosing) and in healthy CYP2D6 poor metaboliser volunteers (single o (0 citation(s)) Click here to download result summary.
105211 phase 2 A randomised, double-blind, placebo-controlled, dose ascending, 2-cohort, parallel group study to examine the safety, tolerability and pharmacokinetics of once-daily inhaled doses of GSK573719 formulated with the excipient Magnesium Stearatein COPD subjects for 7 days (1 citation(s)) Click here to download result summary.
110106 phase 1 A single centre, randomized ,double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects an (0 citation(s)) Click here to download result summary.
112008 phase 1 A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a single 1000μg inhaled dose of GSK573719 in healthy male volunteers. (0 citation(s)) Click here to download result summary.
112014 phase 1 An open-label, two period study to determine the excretion balance and pharmacokinetics of 14C-GSK573719, administered as single dose of an oral solution and an intravenous infusion, to healthy male adults (0 citation(s)) Click here to download result summary.
113073 phase 2 A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects with COPD (1 citation(s)) Click here to download result summary.
113120 phase 2 Safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of GSK573719 and GW642444 in subjects with COPD (1 citation(s)) Click here to download result summary.
113208 phase 1 A single centre, randomised, placebo-controlled, four-way crossover study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK573719 and GW642444 as monotherapies and concurrently in healthy Japanese subjects (1 citation(s)) Click here to download result summary.
113359 phase 3 A 52 week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg once-daily alone and in combination with GW642444 25mcg once-daily via novel Dry Powder Inhaler (nDPI) in Subjects with Chronic Obstructive Pulmonary Disease (0 citation(s)) Click here to download result summary.
113360 phase 3 DB2113360: A multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GW642444 and with tiotropium over 24 weeks in subjects with COPD (0 citation(s)) Click here to download result summary.
113361 phase 3 A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Once-Daily in Subjects with Chronic Obstructive Pulmonary Disease (0 citation(s)) Click here to download result summary.
113373 phase 3 A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Once-Daily in Subjects with Chronic Obstructive Pulmonary Disease (0 citation(s)) Click here to download result summary.
113374 phase 3 DB2113374: A multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GSK573719 and with tiotropium over 24 weeks in subjects with chronic obstructive pulmonary disease (COPD) (0 citation(s)) Click here to download result summary.
113377 phase 1 Phase I study of GSK573719 -A randomized, double blind, placebo controlled, dose ascending, single and repeat dose study to investigate the safety, tolerability, and pharmacokinetics of inhaled dose of GSK573719 from a novel dry powder device in healthy Japanese male subjects - (0 citation(s)) Click here to download result summary.
113589 phase 2 A randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of GSK573719 delivered once-daily over 28 days in subjects with COPD (1 citation(s)) Click here to download result summary.
113950 phase 1 A Single-Centre, Randomised, Open-label Study to Evaluate the Effects of Steady-State Verapamil, a Moderate P-Glycoprotein and CYP3A4 Inhibitor, on the Pharmacokinetics of GSK573719 and GSK573719 in Combination with GW642444 (1 citation(s)) Click here to download result summary.
114417 phase 3 An exercise endurance study to evaluate the effects of treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with a dual bronchodilator: GSK573719/GW642444. Study A (0 citation(s)) Click here to download result summary.
114635 phase 1 A randomised, placebo-controlled, incomplete block, four period crossover , repeat dose study to evaluate the effect of the inhaled GSK573719/Vilanterol combination and GSK573719 monotherapy on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects. (0 citation(s)) Click here to download result summary.
114637 phase 1 An open-label, non-randomized, pharmacokinetic and safety study of single dose GSK573719 + GW643444 (VI) combination and repeat doses of GSK573719 in healthy subjects and in subjects with moderate hepatic impairment (0 citation(s)) Click here to download result summary.
115362 phase 3 A 52-week, Multi-centre, Open-label Study to Evaluate the Safety and Tolerability of GSK573719 125 mcg once-daily in combination with GW642444 25 mcg once-daily via novel Dry Powder Inhaler (nDPI) in Japanese Subjects with Chronic Obstructive Pulmonary Disease. (0 citation(s)) Click here to download result summary.
115487 phase 1 Randomized, double-blind, 5 period cross over study assessing lung function in healthy volunteers following single inhalations of GSK573719 Inhalation Powder from two configurations of the Novel Dry Powder Inhaler (0 citation(s)) Click here to download result summary.
116689 n\a An integrated review to evaluate dose response of umeclidinium (GSK573719) administered once or twice daily in Subjects with COPD (0 citation(s)) Click here to download result summary.
116844 phase 3 Meta-Analysis Results Report for DB2116844: Meta-analysis of DB2113360 and DB2113374: an Integrated Review of Transition Dyspnoea Index data for Umeclidinium/Vilanterol, Umeclidinium, Vilanterol and Tiotropium over 24 Weeks in Subjects with COPD (0 citation(s)) Click here to download result summary.
AC4106889 phase 1 See Detailed Description (0 citation(s)) Click here to download result summary.
AC4108123 phase 2 See Detailed Description (1 citation(s)) Click here to download result summary.