Last updated: 11/03/2018 21:45:56
Post-hoc Analyses of Eosinophil Subgroups using Pooled Data from HZC102871 and HZC102970
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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