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Glaxo and Theravance announce positive Phase 3 results for COPD regimen

  • In two Phase 3 clinical trials, patients with chronic obstructive pulmonary disease (COPD) who received the anticholinergic Incruse Ellipta (umeclidinium 62.5 mcg) or umeclidinium 125 mcg (an unlicensed dose) in addition to Relvar/Breo Ellipta (fluticasone furoate/vilanterol "FF/VI"), an inhaled corticosteroid/long-acting beta2-agonist combination, achieved a statistically significant improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo reports GlaxoSmithKline (GSK) and commercial partner Theravance (THRX).
  • Both studies were 12-week multicenter, randomized, double-blinded placebo-controlled trials involving 1,238 patients with COPD. The primary endpoint was trough forced expiratory volume in one second (FEV1) on Day 85.
  • The full results of the studies will be posted on and presented at a future scientific meeting.
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