Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-10
- Completion
- 2011-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); FF 200 µg OD vs FF/VI 200/25 µg OD; p <0.001; Median Difference (Final Values) 0.193 (95% CI 0.108 to 0.277); ANCOVA NCT01134042 ↗
registry analysis (superiority or other test); FF/VI 200/25 µg OD vs FP 500 µg BID; p <0.001; Median Difference (Final Values) 0.210 (95% CI 0.127 to 0.294); ANCOVA NCT01134042 ↗
registry analysis (superiority or other test); FF 200 µg OD vs FF/VI 200/25 µg OD; p = 0.048; Mean Difference (Final Values) 0.136 (95% CI 0.001 to 0.270); ANCOVA NCT01134042 ↗
registry analysis (superiority or other test); FF/VI 200/25 µg OD vs FP 500 µg BID; p = 0.003; Median Difference (Final Values) 0.206 (95% CI 0.073 to 0.339); ANCOVA NCT01134042 ↗
Publications
- Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563.e1. doi: 10.1016/j.jaip.2020.07.040. Epub 2020 Aug 6. No abstract available.
- 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.
- O'Byrne PM, Bleecker ER, Bateman ED, Busse WW, Woodcock A, Forth R, Toler WT, Jacques L, Lotvall J. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014 Mar;43(3):773-82. doi: 10.1183/09031936.00064513. Epub 2013 Oct 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone Furoate | Other / unclassified | 200 ug | Oral |
| Comparator | Fluticasone propionate | Other / unclassified | 500 ug | Oral |
| Subject | Vilanterol | Other / unclassified | 25 ug | Oral |