Introduction and objectives A new asthma therapy combining fluticasone propionate (FP) and formoterol fumarate (FORM) in a single pressurised metered dose inhaler (FP/FORM) has been developed. The efficacy and safety of FP/FORM (500/20 μg) were compared with its components FP and FORM, administered concurrently (FP+FORM), with FP alone and with FP/FORM (100/10 μg).

Methods Adults with moderate–severe reversible asthma were randomised 1:1:1:1 to 8 weeks of treatment with FP/FORM (500/20 μg or 100/10 μg), FP+FORM (500 μg+24 μg), or FP 500 μg alone (all twice daily) in a double-blind, double-dummy, multicentre, parallel-group study. The primary endpoint was change in mean morning pre-dose FEV₁ from baseline to end of treatment for FP/FORM (500/20 μg) and FP+FORM. Results for FP/FORM (500/20 μg) and FP+FORM are presented.

Results FP/FORM was as effective as FP+FORM, with an increase in mean morning pre-dose FEV₁ of 0.345 l (n=133) and 0.284 l (n=140), respectively at the end of week 8 (per protocol groups; least squares (LS) mean of the treatment difference: 0.060 l; non-inferiority 95% CI:−0.059 to 0.180; p<0.001). The co-primary objective of this study supported this finding. The mean change in FEV₁ from pre-morning dose on Day 0–2 h post-morning dose at end Week 8 was 0.518 l in the FP/FORM group and 0.500 l in the FP+FORM group (per protocol groups; LS mean of the treatment difference: 0.018 l; non-inferiority 95% CI:−0.098 to 0.135; p<0.001). Six patients receiving FP/FORM and 11 patients receiving FP+FORM discontinued due to lack of efficacy (per protocol groups). In both treatment groups, mean asthma symptom scores and sleep disturbance scores were low (intent to treat groups, Day 0: mean asthma symptom scores <1.2; mean sleep disturbance scores <0.7) and improved from Day 0 to end week 8. Salbutamol rescue medication use was comparable (median percentage of study days used: FP/FORM: 23.95%; FP+FORM: 21.05%; Hodges Lehmann difference: 0.06; 95% CI:−4.29 to 4.44; p=0.835). 19.5% of FP/FORM and 19.9% of FP+FORM patients experienced at least one AE. Most AEs were mild or moderate.

Conclusion FP/FORM and FP+FORM had similar efficacy and safety profiles.