Article Text


Clinical and experimental studies in asthma
P16 Fluticasone propionate/formoterol fumarate combination therapy has an efficacy and safety profile similar to that of its individual components administered concurrently: a randomised controlled trial
  1. D Bumbacea1,
  2. A Dymek2,
  3. H Mansikka3
  1. 1Department of Pulmonology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
  2. 2Centrum Medyczne Lucyna Andrzej Dymek, Strzelce Opolskie, Poland
  3. 3Mundipharma Research Limited, Cambridge, UK


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.

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