Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
Summary
The goal of asthma treatment is to achieve and maintain asthma control and to reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most effective anti- inflammatory treatment for all severities of persistent asthma. For children \>=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component) compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old currently uncontrolled on ICS. The study will be conducted over a total duration of approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and 1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870 subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Timeline
- Start
- 2017-10-20
- Primary completion
- 2022-03-21
- Completion
- 2022-03-21
Outcome
Mixed primary results
registry analysis (superiority test); Participants Who Received FF/ VI FDC vs Participants Who Received FF; p <0.001; Least Square Mean Difference 0.083 (95% CI 0.037 to 0.129); ANCOVA NCT03248128 ↗
registry analysis (superiority test); Participants Who Received FF/ VI FDC (5-11 Year Old Population) vs Participants Who Received FF (5-11 Year Old Population); p = 0.228; Least Square Mean Difference 3.2 (95% CI -2.0 to 8.4); ANCOVA NCT03248128 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 50 ug | Inhaled |
| Subject | Fluticasone Furoate | Other / unclassified | 100 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 25 ug | Inhaled |