Last updated: 11/03/2018 23:48:23

PGx7659: Exploratory Pharmacogenetic Investigation of Efficacy Response to Relvar/Breo in Asthma studies 106827, 106829, 106837, 113091 and 116863

GSK study ID
206822
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: PGx7659: Exploratory Pharmacogenetic Investigation of Efficacy Response to Relvar/Breo in Asthma studies 106827, 106829, 106837, 113091 and 116863
Trial description: Fluticasone furoate/vilanterol (FF/VI; RELVAR®/BREO®ELLIPTA®) is a once-daily combination therapy for the long-term treatment of asthma. The objective of this study is to identify genetic variants influencing efficacy response in asthma subjects treated with fluticasone furoate/vilanterol. Genome-wide variants, measured or imputed, will be tested for association with key efficacy endpoints. Candidate genetic variants with previous evidence of effects on asthma and related traits or on response to asthma treatments will be prioritized into a separate tier to test for association.
RELVAR, BREO, and ELLIPTA are trademarks of the GSK Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1)

Timeframe: Study treatment period, i.e., treatment initiation to last dose: HZA106827 (12 weeks), HZA106829 (24 weeks), HZA113091 (24 weeks), HA116863 (12 weeks), and a pre-specified time point for HZA106837 (12 weeks)

Change from baseline weighted mean (WM) 24-hour FEV1 post-dose

Timeframe: Study treatment period, i.e., treatment initiation to last dose: HZA106827 (12 weeks), HZA106829 (24 weeks), HZA113091 (24 weeks) and HZA116863 (12 weeks)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Placebo or other treatment (excluding fluticasone furoate/vilanterol)
  • Drug: FF/VI
    • Enrollment:
    2098
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    July 2016 to November 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 82 Year
    Accepts healthy volunteers
    none
    • Subjects who provided written informed consent and a DNA sample and had clinical outcome data available were included in the study.
    • Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who provided written informed consent and a DNA sample and had clinical outcome data available were included in the study.
    Exclusion criteria:
    • Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    Not applicable
    Actual study completion date
    2016-17-11

    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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