Encruse Ellipta Drug Use Investigation (201450)

Study identification

• EU PAS number:
  EUPAS10224
• Study ID:
  42111
• Official title and acronym:
  Encruse Ellipta Drug Use Investigation (201450)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This investigation will be conducted to collect and evaluate information regarding the safety and efficacy of Encruse ELLIPTA under the actual post-marketing use conditions of the product.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 24/02/2014

Actual: 24/02/2014

Study start date

Planned: 30/11/2015

Actual: 06/04/2016

Date of final study report

Planned: 30/09/2019

Actual: 06/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only