• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to secondary sidebar

OINDPnews


H&T Presspart Low GWP Banner
  • Home
  • News
    • Business
    • Features
    • Medical
    • Regulatory
    • Products and Services
    • People
  • Events
  • Suppliers
    • Supplier listing and advertising options
    • Capsules and blisters
    • Consultants
    • Contract research
    • Contract manufacturing
    • Devices
    • Education
    • Excipients
      • Clinical Technology
    • Filling equipment
    • Instruments
    • Particle manufacturing
    • Software and modeling
  • Jobs
  • Resources
    • Webinars
    • White papers
  • LGWP Propellants
    • HFA 152a
    • HFO-1234ze(E)
    • LGWP Regulation
  • Contact

New Phase 3 study of FF/VI for COPD announced

GSK and Theravance have announced a Phase 3 study of fluticasone furoate (FF)/vilanterol (VI) (the Relvar Ellipta DPI) including Japanese COPD patients. In July 2013, GSK withdrew its application for Relvar for the treatment of COPD in Japan because the available Japanese patient data at the time showed that the FF component failed to produce a statistically significant improvement in lung function.

Relvar Ellipta was approved for asthma in Japan in September 2013.

The new 12-week study looks to include approximately 350 Japanese COPD patients out of 1580 total patients. According to the companies, “Demonstration of a statistically significant contribution of FF 100mcg to the combination on lung function needs to be shown in this study, with a trend demonstrating a positive benefit in the Japanese patients sub-group, being pivotal for the approval of FF/VI 100/25mcg for treatment of COPD in Japan.”

Read the GSK/Theravance press release.

Share

published on April 22, 2014

Primary Sidebar

Sign up for our free weekly newsletter

Upcoming Events
Sponsored by Intertek

Want information about upcoming OINDP-related events delivered directly to your inbox? click here

  • June 17-June 18: Rescon Europe 2025, Paris, France
  • June 19-June 20: Metered Dose Inhaler (MDI) Technology Training Course, online
  • June 22-June 25: ISAM Congress 2025, Washington, DC, USA
  • June 25-June 25: SMI.London 2025, London, UK
  • September 18-September 19: IPAC-RS Nasal Innovation Forum, West Trenton, NJ, USA
  • See all upcoming events

    Secondary Sidebar

    Suppliers

    Capsules and blisters
    Consultants
    Contract research
    Contract manufacturing
    Devices
    Education
    Excipients
    Filling equipment
    Instruments
    Particle manufacturing
    Software and modeling
    Aptar Pharma banner
    © 2025 OINDPnews