An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (204511)

Study identification

• EU PAS number:
  EUPAS11397
• Study ID:
  50502
• Official title and acronym:
  An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (204511)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Democratic People's Republic of
• Study description:
  As a condition of the product approval, the PMS is assigned from national regulatory authority. It’s to monitor the safety and effectiveness of ANORO administered in 3000 Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 23/04/2015

Actual: 23/04/2015

Study start date

Planned: 30/11/2015

Actual: 30/10/2015

Date of final study report

Planned: 09/10/2020

Actual: 18/09/2020

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