Last updated: 11/03/2018 21:45:56

Post-hoc Analyses of Eosinophil Subgroups using Pooled Data from HZC102871 and HZC102970

GSK study ID
201595
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: Post-hoc Analyses of Eosinophil Subgroups using Pooled Data from HZC102871 and HZC102970
Trial description: This study involves post-hoc analyses of eosinophil subgroups using pooled data from the studies HZC102871 and HZC102970. The primary objective of this post-hoc analysis is to evaluate the annual rate of moderate and severe exacerbations in subjects with chronic obstructive pulmonary disease (COPD) over a 52-week treatment period, split by eosinophil levels (<2%, >=2%) at study entry and treatment (fluticasone furoate/vilanterol [FF/VI] 50/25 microgram (mcg), 100/25 mcg or 200/25 mcg or VI 25 mcg). This analysis will use the combined data from studies HZC102871 and HZC102970 to investigate whether blood eosinophil count is a useful biomarker of the long-term effect of the inhaled corticosteroid (ICS) FF treatment on exacerbation frequency. Following screening and a 4-week run-in period during which all eligible subjects received open-label fluticasone propionate/salmeterol, 250/50 mcg to establish a stable baseline, all eligible subjects in studies HZC102871 and HZC102970 were randomized in a 1:1:1:1 ratio to one of the double-blind treatments FF/VI 50/25 mcg, FF/VI 100/25 mcg, FF/VI 200/25 mcg, or VI 25 mcg once daily in the morning for 52 weeks.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annual rate of moderate and severe COPD exacerbations

Timeframe: Up to 52 Weeks

Secondary outcomes:

Change from baseline trough forced expiratory volume in one second (FEV1)

Timeframe: Baseline, Week 12, Week 28 and Week 52

Interventions:
  • Other: Not applicable
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    April 2014 to April 2014
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    none
    • The contributing studies (HZC102871 and HZC102970) enrolled subjects >=40 years of age with a documented clinical history of COPD, defined as subjects with a post-bronchodilator FEV1 of <=70% predicted and an FEV1/forced vital capacity (FVC) ratio <=0.70. In addition, subjects had to have a documented history of at least one COPD exacerbation that required antibiotics and or systemic/oral corticosteroids or hospitalization in the 12 months prior to Visit 1, and a smoking history of >=10 pack-years. Except for short acting anticholinergics, subjects will need to discontinue their use of previous COPD medications prior to run-in.
    • For the post-hoc analysis, subjects who will provide a usable blood sample (to obtain eosinophil levels) will be included.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • The contributing studies (HZC102871 and HZC102970) enrolled subjects >=40 years of age with a documented clinical history of COPD, defined as subjects with a post-bronchodilator FEV1 of <=70% predicted and an FEV1/forced vital capacity (FVC) ratio <=0.70. In addition, subjects had to have a documented history of at least one COPD exacerbation that required antibiotics and or systemic/oral corticosteroids or hospitalization in the 12 months prior to Visit 1, and a smoking history of >=10 pack-years. Except for short acting anticholinergics, subjects will need to discontinue their use of previous COPD medications prior to run-in.
    Exclusion criteria:
    • For the post-hoc analysis, subjects who will provide a usable blood sample (to obtain eosinophil levels) will be included.

    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
    2014-24-04

    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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