A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

Summary

The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children \>=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol \[FP/S\] or budesonide/formoterol \[BUD/F\]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

Timeline

Start

2015-07-09

Primary completion

2017-07-20

Completion

2017-07-20

Publications

• Devillier P, Humbert M, Boye A, Zachgo W, Jacques L, Nunn C, West S, Nicholls A, Antoun Z, Spinu L, Grouin JM. Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting beta2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial. Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.

Drugs

Indications