Last updated: 11/03/2018 23:33:37
Meta-analysis to investigate effect of baseline eosinophils on lung function response to ICS Treatment (GW685698, GW642444M)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-analysis to investigate effect of baseline eosinophils on lung function response to ICS Treatment (GW685698, GW642444M)
Trial description: Previous analyses of chronic obstructive pulmonary disease (COPD) studies have demonstrated that subjects with higher levels of eosinophils at study Baseline experience higher rates of moderate or severe exacerbations. Additionally, these subjects achieved a greater reduction in these exacerbations when treated with inhaled corticosteroid (ICS). The purpose of this analysis is to test similar hypotheses in asthma subjects. 24 Relvar and fluticasone fluorate (FF) phase 2 and 3 studies which collected Baseline eosinophil counts will be included in this meta-analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage predicted FEV1
Timeframe: Day 1
Trough FEV1
Timeframe: Day 1
Change from Baseline (trough) in FEV1 at Week 4
Timeframe: Baseline and Week 4
Change from Baseline (trough) in FEV1 at Week 12
Timeframe: Baseline and Week 12
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
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)
March 2016 to November 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- No specific inclusion criteria is mentioned
- No exclusion criteria is mentioned.
Inclusion and exclusion criteria
Inclusion criteria:
- No specific inclusion criteria is mentioned
Exclusion criteria:
- No exclusion criteria is mentioned.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2017-06-11
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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