Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink (CPRD) study (205052)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48241
• EU PAS number:
  EUPAS17720
• Study ID:
  48241
• Official title and acronym:
  Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink (CPRD) study (205052)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  In the 24-months following the availability of fluticasone furoate / vilanterol (FF/VI) in the United Kingdom, this study will identify new users of FF/VI or other inhaled-corticosteroid/long-acting beta-2-agonist (ICS/LABA) fixed dose combination (FDC) medications from primary care Electronic Medical Records database. Objectives: 1. Separately among new users of FF/VI and other ICS/LABA FDC, describe patient characteristics (incl. demographics, disease burden, selected comorbidities and respiratory medication use) and diagnosis group (asthma, COPD-including an asthma history stratification, other). 2. Among new users of FF/VI, describe off-label prescribing including: • FF/VI 200/25 (pre-dispensed doses, all doses in mcg) formulation in patients with evidence of a COPD diagnosis (only FF/VI 100/25 is licensed for use in patients with COPD) • FF/VI (any dose) in children <12 years of age (neither FF/VI 200/25 nor FF/VI 100/25 is licensed for use in children <12 years of age) 3. Among new users of FF/VI, describe the treatment patterns and adherence to therapy by diagnosis group.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Clinical Practice Research Datalink (CPRD)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 29/07/2016

Actual: 29/07/2016

Study start date

Planned: 01/03/2017

Actual: 04/04/2017

Date of final study report

Planned: 31/07/2017

Actual: 15/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-205052-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)