Study identification

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

Contact details

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor Pharma.CDR@gsk.com

Study contact
Pharma.CDR@gsk.com

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline
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)