Real-life effectiveness evaluation of changing inhaler device for asthma treatment in Korea (Transfform)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19838
• EU PAS number:
  EUPAS12275
• Study ID:
  19838
• Official title and acronym:
  Real-life effectiveness evaluation of changing inhaler device for asthma treatment in Korea (Transfform)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  A historical, observational study to evaluate the real-life effectiveness and cost-effectiveness of asthma treatment in the HIRA Database of Korea specifically examining the switch from the use of dry powder to pressurised metered dose inhalers.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 03/02/2016

Actual: 15/04/2016

Study start date

Planned: 31/03/2016

Actual: 16/09/2016

Data analysis start date

Planned: 29/04/2016

Actual: 23/09/2016

Date of interim report, if expected

Planned: 01/11/2016

Actual: 31/01/2017

Date of final study report

Planned: 02/01/2017

Actual: 11/07/2017

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Mundipharma Asia, RIRL

Study protocol

Initial protocol

20160203_TransfformHIRAv1

Updated protocol

Transfform HIRA Final Study Report_v1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable