5 years ago

Efficacy and safety comparison: Fluticasone furoate and fluticasone propionate, after step down from fluticasone furoate/vilanterol in Japanese patients with well-controlled asthma, a randomized trial

For patients with well-controlled asthma, ‘step down’ of therapy is recommended. We evaluated Japanese patients switching from inhaled corticosteroid (ICS)/long-acting beta2-agonists (LABA; equivalent to fluticasone propionate [FP]/salmeterol [SAL] 250/50 μg twice daily [BD]) to fluticasone furoate (FF)/vilanterol (VI) 100/25 μg, then stepping down to ICS alone. Methods This phase III trial had two treatment periods (P): P1, patients with well-controlled asthma on FP/SAL 250/50 μg BD equivalent stepped across to once daily (OD) FF/VI 100/25 μg (open-label, eight weeks); P2, patients remaining ‘well controlled’ after P1 stepped down to FF 100 μg OD/FP 100 μg BD/FP 250 μg BD (randomized 1:1:1, double-blind, 12 weeks). Co-primary P2 endpoints: percentage of patients with well-controlled asthma; time to withdrawal due to poorly controlled asthma requiring step-up therapy. Adverse events (AEs) were monitored. Results At the end of P1 (n = 430), 373/415 (89.9%; 95% confidence interval 86.57–92.61) patients' asthma remained well controlled with FF/VI; in P2 (n = 371), control was maintained in 89.5% (FF 100 μg)/78.2% (FP 100 μg)/83.1% (FP 250 μg) of patients. In P2, 4.9–8.1% of patients were withdrawn due to worsening asthma (time-to-withdrawal cumulative incidence curves were comparable). AEs were reported by 37% of patients during P1; and by 36% (FF 100 μg)/48% (FP 100 μg)/49% (FP 250 μg) of patients in P2. Conclusions For patients with well-controlled asthma on mid dose ICS/LABA (equivalent to FP/SAL 250/50 μg BD), control can be maintained when they are stepped across to FF/VI 100/25 μg OD. FF 100 μg OD is an effective step-down therapy from FF/VI 100/25 μg OD with similar efficacy to FP 100 μg BD and FP 250 μg BD.

Publisher URL: www.sciencedirect.com/science

DOI: S0954611116302517

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.