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
Finalized
Finalized
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:
Drug: Salmeterol
Drug: Fluticasone propionate / salmeterol
Drug: FLuticasone furoate / vilanterol
Drug: Formoterol
Drug: Budesonide /formoterol
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
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
Finalized
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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