Real life effectiveness and cost impact evaluation of fixed dose combination fluticasone propionate/formoterol (Flutiform®) compared to fluticasone propionate/salmeterol (Seretide®) (eFFectiveness)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/12632
• EU PAS number:
  EUPAS12631
• Study ID:
  12632
• Official title and acronym:
  Real life effectiveness and cost impact evaluation of fixed dose combination fluticasone propionate/formoterol (Flutiform®) compared to fluticasone propionate/salmeterol (Seretide®) (eFFectiveness)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study examines the effectiveness and cost impact of treatment with an inhaled corticosteroid/long acting beta agonist (ICS/LABA) either as fluticasone propionate/formoterol (FP/FOR) or fluticasone propionate/salmeterol (FP/SAL) in asthmatic patients extracted from the optimum patient care database (OPCD).
• Study status:
  Finalised

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/01/2014

Actual: 30/03/2014

Study start date

Planned: 02/03/2015

Actual: 02/03/2016

Data analysis start date

Planned: 03/08/2015

Actual: 24/08/2015

Date of interim report, if expected

Planned: 17/03/2016

Actual: 01/03/2016

Date of final study report

Planned: 29/04/2016

Actual: 02/03/2016

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Napp, RIRL

Study protocol

Initial protocol

150519_R03212c_Napp_Flutiform_switch_study3_protocol_V2.0_AT.compressed

Regulatory

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