Last updated: 02/07/2020 16:50:22
Meta-analysis of Arnuity (FF) studies FFA109685 & FFA112059 Direct comparison of FF100 QD and FP 250 BD for Trough FEV1
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Meta-analysis of Arnuity (FF) studies FFA109685 & FFA112059 Direct comparison of FF100 QD and FP 250 BD for Trough FEV1
Trial description: A meta-analysis of Fluticasone Furoate (FF) studies FFA109685 & FFA112059 to provide a direct comparison of FF100 QD and FP 250 BD for the primary efficacy end-point of Trough forced expiratory volume in 1 (FEV1) for the maintenance treatment of asthma in patents aged 12 years and older. The Meta-analysis will be conducted using a frequentist approach (DerSimonian-Laird random effects model) as required by the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from baseline in clinic visit mean trough FEV1
Timeframe: Up to 24 Weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone propionate
Drug: Fluticasone furoate
Enrollment:
0
Observational study model:
Other
Primary completion date:
2015-23-04
Time perspective:
Retrospective
Clinical publications:
Ryan Tomlinson, Dan Parks, Alan Martin. Comparative meta-analysis of the efficacy of once-daily fluticasone furoate 100 mcg versus twice-daily fluticasone propionate 250 mcg in adolescents and adults with persistent asthma. Lung. 2017;195(5):571-574
Medical condition
Asthma
Product
GW597901, fluticasone furoate, fluticasone propionate, fluticasone propionate/GW597901
Collaborators
Not applicable
Study date(s)
April 2015 to April 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- NA
- NA
Inclusion and exclusion criteria
Inclusion criteria:
- NA
Exclusion criteria:
- NA
Trial location(s)
No location data available.
Study documents
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
2015-23-04
Actual study completion date
2015-23-04
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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