Last updated: 11/07/2018 11:46:00
Evidence Synthesis and Meta-Analysis Framework for Evaluating Treatments for COPD Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evidence Synthesis and Meta-Analysis Framework for Evaluating Treatments for COPD Patients
Trial description: The primary objective is to evaluate the relative treatment efficacy of fluticasone furoate/vilanterol (FF/VI) compared with alternative inhaled corticosteroids/long-acting beta-agonist (ICS/LABAs) licensed for the treatment of Chronic Obstructive Pulmonary Disease (COPD), based on lung function measured as the forced expiratory volume in 1 second (FEV1) change from baseline. The primary comparisons will include European Union (EU)-authorised fixed dose treatment regimens: - FF/VI compared with fluticasone propionate and salmeterol - FF/VI compared with budesonide and formoterol Secondary objectives are to evaluate FF/VI versus the comparators on: - Yearly or annualized rate of the composite moderate/severe exacerbations - Yearly or annualized rate of any exacerbations - St. George's Respiratory Questionnaire (SGRQ) Study Design: Bayesian, hierarchical, mixed treatment comparisons (MTCs) Data Source: Systematic literature review of COPD treatments that was conducted separately Analysis: Models will include known predictors of treatment outcomes. Exacerbation endpoint will be analyzed in patients with a history of exacerbations as documented in the supporting clinical trial publications.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
FEV1: mean change from baseline
Timeframe: >8 weeks
Secondary outcomes:
Health status: St. Georges Respiratory Questionnaire (SGRQ)
Timeframe: >8 weeks
rate of moderate and severe exacerbations
Timeframe: >8 weeks
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Stynes G, Svedsater H, Wex J, Lettis S, Leather D, Castelnuovo E, Detry M, Berry S. Once-daily fluticasone furoate/vilanterol 100/25mcg versus twice daily combination therapies in COPD - mixed treatment comparisons of clinical efficacy. Respir Res. 2015;16:25.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
July 2013 to October 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- Phase III or IV randomised trials of the treatment of adult and adolescents (>=12 years) with chronic obstructive pulmonary disease with at least one arm on ICS/LABA
- Studies >8 weeks of follow-up
Inclusion and exclusion criteria
Inclusion criteria:
- Phase III or IV randomised trials of the treatment of adult and adolescents (>=12 years) with chronic obstructive pulmonary disease with at least one arm on ICS/LABA
- Studies >8 weeks of follow-up
- Studies reporting endpoints of interest
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2013-17-10
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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