drugset / Trial / NCT01436071
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids
Timeline
- Start
- 2011-09
- Primary completion
- 2012-06
- Completion
- 2012-08
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN Placebo: 0.038 (Standard Error 0.0333) Liters NCT01436071 ↗
registry LEAST_SQUARES_MEAN FF 50 µg OD: 0.157 (Standard Error 0.0330) Liters NCT01436071 ↗
registry analysis (superiority or other test); Placebo vs FF 50 µg OD; p = 0.012; Median Difference (Final Values) 0.120 (95% CI 0.026 to 0.213); ANCOVA NCT01436071 ↗
Publications
- O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
- O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lotvall J, Forth R, Medley H, Jacques L, Busse WW. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respir Res. 2014 Aug 11;15(1):88. doi: 10.1186/s12931-014-0088-z.
- Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 50 ug | Inhaled |