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 subgroup analysis comparing FLUT/FORM 500/20 µg vs. FLUT+FORM 500 µg + 24 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 Similar improvements in lung function (change in pre-dose FEV1 and change in 2-hour post-dose FEV1) were seen in the FLUT/FORM 500/20 µg treatment group and the FLUT+FORM 500 µg + 24 µg treatment group overall [treatment difference 0.079 (95% CI: –0.032, 0.190) P=0.164 and treatment difference 0.040 (95% CI –0.069, 0.149) P=0.471, respectively]. Both severe and moderate asthmatic subgroups demonstrated mean changes from baseline approximating or exceeding a minimally important improvement (200 mL)1 with similar efficacy in the FLUT/FORM 500/20 µg and the FLUT+FORM 500 µg + 24 µg moderate and severe subgroups (Table 1).
There were no statistically significant or clinically relevant differences overall or in either of the subgroups between FLUT/FORM 500/20 µg and FLUT+FORM 500 µg + 24 µg for any symptom-based endpoints. These included asthma symptom scores, sleep disturbance scores, rescue medication use and asthma control days.
Conclusion FLUT/FORM and FLUT+FORM demonstrated similar improvements in lung function (pre-dose and 2hour post dose FEV1) and symptom-based endpoints in the overall population, and in both subgroups.
Statistics from Altmetric.com
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.