Article Text


Clinical and experimental studies in asthma
P24 Fluticasone propionate/formoterol fumarate combination therapy has a more rapid onset of action than fluticasone propionate/salmeterol xinafoate in the treatment of asthma: a randomised controlled trial
  1. A Bodzenta-Lukaszyk1,
  2. A Dymek2,
  3. H Mansikka3
  1. 1Clinical Department of Allergology and Internal Diseases, Uniwersytet Medyczny w Białymstoku, Białystok, Poland
  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 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.

Statistics from

Request Permissions

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.