Last updated: 11/07/2018 11:15:49

PGx6304: Detailed evaluation of potential role of genetic variation within GLCCI1 and its influence on steroid response

GSK study ID
116963
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: PGx6304: Detailed evaluation of potential role of genetic variation within GLCCI1 and its influence on steroid response
Trial description: Tantisira, et al. (2011), reported an association between the genetic marker rs37973, which is in the gene GLCCI1 (glucocorticoid-induced transcript 1), and response to treatment with inhaled corticosteroids in non-Hispanic, white patients with asthma. The overall objective of this pharmacogenetic analysis is to attempt to confirm the finding of Tantisira, et al., by retrospectively testing for an association between rs37973 and measures of steroid response in subjects treated with fluticasone furoate (FF) or fluticasone propionate (FP) in GSK studies FFA109684, FFA109685, FFA109687, HZA106827, HZA106829, HZA106837, and FFA112059.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in forced expiratory volume in one second (FEV1) from baseline, using last observation carried forward to impute missing values

Timeframe: Change in FEV1 from baseline will be assessed after eight weeks of treatment or at the next scheduled assessment.

Secondary outcomes:

Membership in the lowest or highest quartile of change in FEV1 from baseline.

Timeframe: Membership in the lowest or highest quartile of change in FEV1 from baseline will be based on change in FEV1 after eight weeks of treatment or at the next scheduled visit.

Interventions:
  • Drug: fluticasone propionate
  • Drug: fluticasone furoate
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Louise Hosking, Eugene Bleecker, Soumitra Ghosh, Astrid Yeo, Loretta Jacques, Michael Mosteller, Deborah Meyers.GLCCI1 rs37973 does not influence treatment response to inhaled corticosteroids in white subjects with asthma.J Allergy Clin Immunol.2014;133(2):587-9
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to July 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 84 Year
    Accepts healthy volunteers
    none
    • subjects satisfying the inclusion criteria for their respective clinical studies
    • subjects must have provided written informed consent and a DNA sample for pharmacogenetic research
    • when testing for the significance of an additive effect of rs37973 on membership in the lowest quartile versus the highest quartile of FEV1 response, subjects in the middle two quartiles will be excluded from the analysis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • subjects satisfying the inclusion criteria for their respective clinical studies
    • subjects must have provided written informed consent and a DNA sample for pharmacogenetic research
    Exclusion criteria:
    • when testing for the significance of an additive effect of rs37973 on membership in the lowest quartile versus the highest quartile of FEV1 response, subjects in the middle two quartiles will be excluded from the analysis.

    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
    Not applicable
    Actual study completion date
    2012-26-07

    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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