Real-life effectiveness evaluation of budesonide/formoterol (BF) Spiromax for the management of asthma and COPD

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17275
• EU PAS number:
  EUPAS13238
• Study ID:
  17275
• Official title and acronym:
  Real-life effectiveness evaluation of budesonide/formoterol (BF) Spiromax for the management of asthma and COPD
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Four complimentary post-marketing retrospective observational studies to evaluate the real-life effectiveness and cost-effectiveness of BF Spiromax and to characterise patients prescribed BF Spiromax in the two years following product launch in the United Kingdom
• 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: 20/03/2015

Actual: 20/03/2015

Study start date

Planned: 16/09/2015

Actual: 16/09/2015

Data analysis start date

Planned: 09/05/2016

Date of interim report, if expected

Planned: 29/01/2016

Actual: 29/01/2016

Date of final study report

Planned: 03/02/2017

Actual: 16/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceutical Industries

Study protocol

Initial protocol

160301_R00615_Spiromax_Protocol_V3.0

Regulatory

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