Introduction and objectives A new asthma therapy combining fluticasone propionate and formoterol fumarate (FP/FORM) in a single pressurised metered dose inhaler has been shown to have similar efficacy and safety to fluticasone propionate/salmeterol xinafoate (FP/SAL). Secondary endpoint data for this study are presented here.
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. The primary endpoint was mean morning pre-dose FEV1 at Week 12. Secondary endpoints included time to onset of action. Time to onset of action was defined as the first time point post-dose at which the FEV1 value was at least 12% greater than the pre-dose value (Abstract P24 Figure 1).
Results FP/FORM time to onset of action was more rapid than FP/SAL (HR: 1.64; 95% CI: 1.28 to 2.10; p<0.001; full analysis population; FP/FORM: n = 101; FP/SAL: n = 100). Onset of action was observed on Day 0 in 78 patients in the FP/FORM group and 64 patients in the FP/SAL group. The probability of onset of action occurring was higher in the FP/FORM group than in the FP/SAL group at each post-dose time point on Days 0, 14, 42 and 84. 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. Overall, the rate of AEs was comparable (23.8%; 24/101 for both groups). Most AEs were mild or moderate. There were only two severe AEs, both in the FP/FORM group. The frequency of treatment-related AEs was very low in both groups (FP/FORM: n = 1; FP/SAL: n = 1). Clinical laboratory results and vital sign assessments showed no abnormal results. No clinically important ECG changes were observed. Overall, FP/FORM and FP/SAL safety and tolerability profiles were similar.
Conclusion FP/FORM improved lung function more rapidly than FP/SAL.