drugset / Trial / NCT01165138
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
Timeline
- Start
- 2010-08-20
- Primary completion
- 2011-10-01
- Completion
- 2011-10-19
Outcome
Met primary endpoint
registry Placebo vs FF/VI 100/25 µg OD; p <0.001; Median Difference (Final Values) 0.172 (95% CI 0.087 to 0.258); ANCOVA NCT01165138 ↗
registry Placebo vs FF/VI 100/25 µg OD; p <0.001; Median Difference (Final Values) 0.302 (95% CI 0.178 to 0.426); ANCOVA NCT01165138 ↗
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.
- Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
- Bleecker ER, Lotvall J, O'Byrne PM, Woodcock A, Busse WW, Kerwin EM, Forth R, Medley HV, Nunn C, Jacques L, Bateman ED. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61. doi: 10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.
- 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.
- Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 100 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 25 ug | Inhaled |