Last updated: 04/01/2021 08:50:04

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

GSK study ID
205052
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink (CPRD) study
Trial description: In accordance with the pharmacovigilance plan agreed for FF/VI, this study will provide information on the ‘real-world’ utilization of FF/VI in the early post-approval period including potential off-label prescribing. The objectives of the study will be to collect characteristics of new users of FF/VI or other inhaled corticosteroid (ICS)/ long-acting beta2 agonist (LABA) fixed-dose-combination (FDC); ascertainment of off-label use; and treatment patterns and adherence. This study will take a naturalistic approach, capturing routine medical care using a retrospective longitudinal non-interventional observational design. All subjects with a record of a new prescription for FF/VI or other ICS/LABA FDC during the inclusion period of 01-Jan-2014 through 31-Dec-2015 (corresponding to the period of 24 months from the start of FF/VI availability in the United Kingdom [UK]) will be identified and assessed for eligibility to be included in this study. This study will use the Clinical Practice Research Datalink’s (CPRD)-General practitioner (GP) OnLine Database (CPRD-GOLD), a UK primary care electronic medical record (EMR) database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Characteristics of new users of FF/VI or other ICS/LABA FDC

Timeframe: At index

Off-label use

Timeframe: At index and within 12 months from index

Treatment patterns and adherence

Timeframe: At index and within 12 months from index

Secondary outcomes:
Not applicable
Interventions:
  • Drug: ICS/LABA FDC
  • Drug: FF/VI FDC
    • Enrollment:
    1
    Primary completion date:
    2017-31-07
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Daniel Dedman, Sonia J. Coton, Rebecca E. Ghosh, Wilhelmine Meeraus, Courtney Crim, Catherine Harvey, Justyna Amelio, Sarah H. Landis. Treatment patterns of new users of fluticasone furoate/vilanterol in asthma and COPD in UK primary care: a retrospective cohort study. Pulm Ther. 2019;4(7):1-15 DOI: 10.1007/s41030-019-0092-z
    Medical condition
    Pulmonary Disease, Chronic Obstructive, Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Clinical Practice Research Datalink (CPRD)
    Study date(s)
    April 2017 to July 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    None
    • Record of a new prescription of FF/VI or other ICS/LABA FDC during the inclusion period (01-Jan-2014 through 31-Dec-2015).
    • Greater than or equal to 12 months of registration at a practice with ‘up to standard data’ recording prior to index prescription date to allow for characterization of subject’s status, demographics and clinical characteristics.
    • Past record ever in medical history of prescription for the specific inclusion medication (prior use of another ICS/LABA FDC product will be permitted).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Record of a new prescription of FF/VI or other ICS/LABA FDC during the inclusion period (01-Jan-2014 through 31-Dec-2015).
    • Greater than or equal to 12 months of registration at a practice with ‘up to standard data’ recording prior to index prescription date to allow for characterization of subject’s status, demographics and clinical characteristics.
    Exclusion criteria:
    • Past record ever in medical history of prescription for the specific inclusion medication (prior use of another ICS/LABA FDC product will be permitted).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-07
    Actual study completion date
    2017-31-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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