An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and efficacy of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (205163)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40153
• EU PAS number:
  EUPAS14947
• Study ID:
  40153
• Official title and acronym:
  An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and efficacy of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (205163)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Incruse administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice
• Study status:
  Finalised

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Je-Ju National University Hospital Je-Ju, Korea

Study timelines

Date when funding contract was signed

Planned: 13/10/2015

Actual: 13/10/2015

Study start date

Planned: 31/08/2016

Actual: 23/08/2016

Date of final study report

Planned: 09/10/2020

Actual: 03/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-205163-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable