Last updated: 04/04/2025 12:00:44

PGx7684: Confirmatory pharmacogenetic study investigating IL13 association with efficacy response to fluticasone furoate/vilanterol in asthma study 201378

GSK study ID
207933
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: PGx7684: Confirmatory pharmacogenetic study investigating IL13 association with efficacy response to fluticasone furoate/vilanterol in asthma study 201378
Trial description: Confirmatory pharmacogenetic evaluation using clinical data from study 201378 of one SNP, rs2243204, and flanking variants in the IL13 gene region that was associated with the FF/VI; GW685698/GW642444; Relvar® Ellipta® efficacy endpoint of change from Baseline in trough forced expiratory volume in one second (FEV1) at the end of study treatment period as identified in the completed PGx7659 study (Study ID 206822). PGx7659 utilized clinical data from asthma studies 106827, 106829, 106837, 113091 and 116863. RELVAR 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 evening (PM) FEV1 (pre-bronchodilator and pre-dose)

Timeframe: Study treatment period, i.e., treatment initiation to last dose: 24 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone furoate/vilanterol
    • Enrollment:
    0
    Primary completion date:
    2017-16-06
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    June 2017 to June 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    none
    • Subjects who provided written informed consent and a deoxyribonucleic acid (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 deoxyribonucleic acid (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

    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
    2017-16-06
    Actual study completion date
    2017-16-06

    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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