Introduction and Objectives A new asthma therapy combining fluticasone propionate and formoterol fumarate (FP/FORM) in a single pressurised metered dose inhaler has been developed. The efficacy and safety of FP/FORM and fluticasone propionate/salmeterol xinafoate (FP/SAL) therapy were compared.
Methods Adults (N=202) with mild to moderate-severe asthma were randomised 1:1 to 12 weeks of treatment with FP/FORM (100/10 μg or 250/10 μg) or FP/SAL (100/50 μg or 250/50 μg), both twice daily, in an open-label, parallel-group, multicentre study. The starting dose was based on the dose of inhaled corticosteroid the patient received before the study. Lung function and safety assessments were made during the 12-week period. The primary endpoint was mean morning pre-dose FEV1 at Week 12.
Results FP/FORM was as effective as FP/SAL, with a least squares (LS) mean difference in morning pre-dose FEV1 at Week 12 of –0.061 L between treatments. Non-inferiority of FP/FORM to FP/SAL was demonstrated (the lower limit of the 95% CI exceeded the acceptance limit of –0.2 L). Pre-dose FEV1 increased in both groups from baseline to Week 12 (FP/FORM: +0.196 L; FP/SAL: +0.257 L). The LS mean difference in change in pre-dose FEV1 was –0.061 L between treatments (95% CI –0.161 to 0.040). Non-inferiority of FP/FORM to FP/SAL was demonstrated (the lower limit of the 95% CI exceeded the acceptance limit of –0.2 L). In total, 72.3% (73/101) patients started on FP/FORM 250/10 μg and 75.2% (76/101) on FP/SAL 250/50 μg. Eight patients (FP/FORM: n=5; FP/SAL: n=3) required an increase in dose. Similar numbers of patients treated with FP/FORM and FP/SAL discontinued due to lack of efficacy (FP/FORM: n=1; FP/SAL: n=2). Twenty-three patients (11.4%) experienced mild or moderate asthma exacerbations. Four patients (2.0%) experienced severe exacerbations (FP/FORM: n=3; FP/SAL: n=1; p=0.621). Overall, 23.8% of patients experienced at least one AE. The rate was the same in both treatment groups (24/101). Most AEs were mild or moderate. No clinically important changes in laboratory results, vital signs or ECGs were observed.
Conclusion FP/FORM and FP/SAL had similar efficacy and safety profiles.