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A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

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Trial Profile

A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2023

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At a glance

  • Drugs Revefenacin (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan

    • Most Recent Events

    • 18 Jan 2023 Results of post hoc analysis evaluating improvement in patient reported outcomes (PROs), including the St. Georges Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men published in the Respiratory Medicine
    • 19 Oct 2022 Results post hoc analysis (n=812 of two phase 3 trials NCT02459080; NCT02512510) assessing Patient-Reported Outcomes with Revefenacin in Adults with Moderate to Very Severe Copd and Comorbid Anxiety or Depressionpresented at the CHEST Annual Meeting 2022 by Annual Meeting of the American College of Chest Physicians
    • 19 May 2021 Results of subgroup analyses (n=812) assessing the efficacy and safety of revefenacin in improving lung function in women versus men with moderate to very severe chronic obstructive pulmonary disease from Study 0126 (NCT02459080), 0127 (NCT02512510) and Study 0128 (NCT02518139) trials, presented at the 117th International Conference of the American Thoracic Society.
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