A Phase 3, 52-week, Randomized, Active−Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD−4208 in Subjects With Chronic Obstructive Pulmonary Disease

Trial Profile

A Phase 3, 52-week, Randomized, Active−Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD−4208 in Subjects With Chronic Obstructive Pulmonary Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2017

At a glance

  • Drugs Revefenacin (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Theravance Biopharma
  • Most Recent Events

    • 13 Nov 2017 According to a Theravance Biopharma media release, the company has submitted a New Drug Application (NDA) to the US FDA for revefenacin intended to treat chronic obstructive pulmonary disease (COPD). The application is supported by data from this and two other phase III trials.
    • 01 Nov 2017 According to a Theravance Biopharma media release, filing of New Drug Application (NDA) is planned in the fourth quarter of 2017.
    • 19 Jul 2017 Results published in a Theravance Biopharma Media Release.
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