Drug Use Investigation of ANORO ELLIPTA inhaler (200311)

Study identification

• EU PAS number:
  EUPAS9868
• Study ID:
  48235
• Official title and acronym:
  Drug Use Investigation of ANORO ELLIPTA inhaler (200311)
• 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 ANORO ELLIPTA under the actual post-marketing use conditions of the product.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Iwamizawa Municipal General Hospital Iwamizawa, Japan

Study timelines

Date when funding contract was signed

Planned: 15/03/2013

Actual: 15/03/2013

Study start date

Planned: 20/02/2015

Actual: 20/02/2015

Data analysis start date

Actual: 03/07/2019

Date of final study report

Planned: 31/12/2019

Actual: 31/10/2019

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