Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41147
• EU PAS number:
  EUPAS7761
• Study ID:
  41147
• Official title and acronym:
  Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study primarily aims to collect data reflecting the real-world experience with UMEC/VI and UMEC in the post-approval setting (period of up to 24 months from the start of UMEC/VI and UMEC availability in the United Kingdom). The study will use a retrospective longitudinal non-interventional observational study design to identify patients based on a new prescription (index prescription date) for UMEC/VI, UMEC, or other long acting bronchodilators (LABD). These patients will be followed-up from their index prescription date until censoring at death, leaving practice, or end of follow-up at 30 June 2017.
• Study status:
  Finalised

Research institution and networks

Institutions

Clinical Practice Research Datalink (CPRD)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 04/06/2014

Actual: 04/06/2014

Study start date

Planned: 01/03/2015

Actual: 11/09/2014

Date of final study report

Planned: 31/12/2019

Actual: 10/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

117397-protocol-redact (UPDATED)

Updated protocol

gsk-117397-protocol-redact-v02

Regulatory

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