drugset / Trial / NCT01147848
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily 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
- 2011-07
- Completion
- 2011-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Fluticasone Furoate/Vilanterol 100/25 µg OD vs Fluticasone Propionate/Salmeterol 250/50 µg BID; p = 0.162; Least Squares Mean Difference -0.037 (95% CI -0.088 to 0.015); ANCOVA NCT01147848 ↗
Publications
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Woodcock A, Bleecker ER, Lotvall J, O'Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013 Oct;144(4):1222-1229. doi: 10.1378/chest.13-0178.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 100 ug | Oral |
| Comparator | Fluticasone propionate | Other / unclassified | 250 ug | Oral |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Oral |
| Subject | Vilanterol | Other / unclassified | 25 ug | Oral |