Last updated: 02/04/2020 14:10:08
HO-14-15413 - Evidence Synthesis and Mixed Treatment Comparison of Efficacy of Treatments for the Maintenance of Asthma (annual updates)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: HO-14-15413 - Evidence Synthesis and Mixed Treatment Comparison of Efficacy of Treatments for the Maintenance of Asthma (annual updates)
Trial description: This study will update the original mixed treatment comparison (MTC) of fluticasone furoate/vilanterol (FF/VI) in comparison to alternative inhaled corticosteroid/long-acting beta-agonists (ICS/LABAs) in asthma (carried out in 2013; study id 200341) with recent literature (studies published since December 2012).The primary objective is to evaluate the relative treatment efficacy of FF/VI compared with alternative ICS/LABAs licensed for the treatment of Asthma, based on lung function measured as mean change from baseline in morning Peak Expiratory Flow (PEF) (averaged over the study period), and mean change from baseline in FEV1. The primary comparisons will include European Union (EU)-authorised fixed dose treatment regimens: 1) FF/VI compared with fluticasone propionate and salmeterol; 2) FF/VI compared with budesonide and formoterol; 3) FF/VI compared with budesonide propionate and formoterol; 4) FF/VI compared with fluticasone propionate and formoterol. Secondary objectives are to evaluate FF/VI versus the comparators on: 1) Yearly or annualized rate of the composite moderate/severe exacerbations; 2) Yearly or annualized rate of any exacerbations; 3) Asthma Quality of Life Questionnaire (AQLQ); Study Design: Bayesian, hierarchical, mixed treatment comparisons (MTCs) Data Source: Systematic literature review of Asthma treatments that was conducted separately. Analysis: Analyses will be conducted, contingent upon availability of comparator data. 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.RELVAR is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
PEF: mean change from baseline
Timeframe: >8 weeks
FEV1: mean change from baseline
Timeframe: >8 weeks
Secondary outcomes:
Asthma Quality of Life Questionnaire (AQLQ)
Timeframe: >8 weeks
Rate of moderate and severe exacerbations
Timeframe: >8 weeks
Interventions:
Enrollment:
0
Primary completion date:
2015-16-06
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Henrik Svedsater, Gillian Stynes, Jaro Wex, Lucy Frith, David Leather, Emanuela Castelnuovo, Michelle Detry, Scott Berry. Once-daily fluticasone furoate/vilanterol versus twice-daily combination therapies in asthma - mixed treatment comparisons of clinical efficacy. Asthma Res Prac. 2016;2:4.
- Phase III or IV randomized trials of the treatment of adults and adolescents (>=12 years) with asthma with at least one arm on ICS/LABA
- Studies >8 weeks of follow up
Inclusion and exclusion criteria
Inclusion criteria:
- Phase III or IV randomized trials of the treatment of adults and adolescents (>=12 years) with asthma with at least one arm on ICS/LABA
- Studies >8 weeks of follow up
- Patients uncontrolled or symptomatic at randomization
- 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
2015-16-06
Actual study completion date
2015-16-06
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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