Article Text

PDF

Treating asthma
P12 Fluticasone propionate/formoterol fumarate combination therapy: treatment effects in patients by baseline asthma severity across the dose range
  1. T McIver,
  2. B Grothe,
  3. M Jain,
  4. S Dissanayake
  1. Mundipharma Research Limited, Cambridge, United Kingdom

Abstract

Background A new asthma therapy containing a combination of the inhaled steroid fluticasone propionate (FLUT) and the long-acting β2 agonist (LABA) formoterol fumarate (FORM) in a metered-dose inhaler has been developed (FLUT/FORM; flutiform®). In a double-blind, double-dummy, randomised, multicentre, four arm parallel group study, the efficacy and safety of FLUT/FORM vs. FLUT and FORM administered concurrently (FLUT+FORM) was assessed. Here, we present efficacy results of a posthoc analysis that compared FLUT/FORM 500/20 µg with FLUT/FORM 100/10 µg (both twicedaily) by baseline asthma severity.

Methods In total, 620 patients were randomised 1:1:1:1 to receive FLUT/FORM 500/20 µg, FLUT/FORM 100/10 µg, FLUT+FORM 500 µg + 24 µg or FLUT 500 µg. Randomisation was stratified by percentage predicted FEV1 at baseline [≥40 – ≤60% (‘severe asthma’; 52% of patients) vs. >60% – ≤80% (‘moderate asthma’; 48% of patients)], allowing a post-hoc dichotomised analysis by baseline FEV1 severity of spirometric and symptom-based endpoints.

Results There was no dose-response relationship between FLUT/FORM 500/20 µg and FLUT/FORM 100/10 µg for the spirometric variables overall or in either subgroup.

Treatment effect differences between FLUT/FORM 500/20 µg and 100/10 µg, in favour of the high dose, were however evident for almost all symptom-based endpoints and were more pronounced in the severe asthma group. These included changes in: mean symptom scores, percentage symptomfree days, mean sleep disturbance scores, awakening free nights, percentage rescue medication-free days, percentage asthma control days, AQLQ score and the incidence of any asthma exacerbations. The differences between FLUT/FORM 500/20 µg and 100/10 µg in the severe asthma group were significant at the 5% level for sleep disturbance scores [treatment difference –0.138 (95% CI: –0.265, –0.012) P=0.032], percentage awakeningfree nights [treatment difference 11.754 (95% CI: 2.234, 21.274) P=0.016] and mean AQLQ score [treatment difference 0.302 (95% CI: 0.013, 0.591) P=0.041].

Conclusion High dose FLUT/FORM (500/20 µg) was consistently associated with greater symptomatic treatment benefit than low dose (100/10 µg) treatment in patients with severe asthma. These data provide a rationale for dose escalation with FLUT/FORM, which appears most likely to confer additional treatment benefit in patients with severe asthma.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.