Data presented at the European Respiratory Society (ERS) congress demonstrate that a new fixed-dose combination therapy of fluticasone propionate (FP), an inhaled corticosteroid, and formoterol fumarate (FORM), a long-acting β2-agonist, is as effective in treating asthma as one of the current market leaders in Europe, fluticasone propionate/salmeterol xinafoate (FP/SAL), but has a more rapid onset of action1. The FP/FORM combination has also been shown to be more effective in controlling asthma symptoms than FP alone2.
Despite a range of available therapies, many asthma patients still require unscheduled urgent care or emergency hospital admissions3,4, which suggests that there is a need for alternative treatment approaches which may deliver more effective asthma management5.
The FP/FORM combination brings together the attributes of the two compounds: fluticasone propionate, the most widely prescribed inhaled corticosteroid in Europe*6 and formoterol fumarate, a long-acting β2-agonist characterised by a fast onset of action7,8.
“There are still many challenges with achieving optimal control in asthma patients – said Prof. David Price, Centre of Academic Primary Care, University of Aberdeen, United Kingdom – The data presented today demonstrate the good efficacy profile of the FP/FORM combination and reinforce its potential to become an alternative treatment option for people with asthma.”
There is evidence to suggest, that the type of device is one of the factors which influences treatment outcomes in asthma patients9. Data presented at ERS from a GPRD retrospective study demonstrate that in real-world combination therapy, patients using pressurised metered dose inhaler (pMDI) appear to achieve better outcomes (asthma control and exacerbations) than those using dry powder inhalers (DPIs)10. In the FP/FORM studies1,2 both patient groups were administered their combination in the pMDI.
The development of the new combination, filed with European regulatory authorities in the first half of 2010, signals the entrance of Mundipharma in the asthma marketplace, and their commitment to drive advancements in the area of respiratory disease. The combination was developed by Mundipharma in partnership with SkyePharma.
“The efforts of Mundipharma are focused on developing therapies which address existing unmet needs in asthma and deliver clinical benefits that enable patients to live better and more fulfilled lives through the optimal control of their condition. “ – said Professor Dr. Karen Reimer, European R&D Director at Mundipharma.
FLT3501 was an open-label, parallel-group, multicentre study with FP/FORM (250/10 µg) or FP/SAL (250/50 µg) administered twice daily. The primary endpoint was mean morning pre-dose FEV1 at Week 12. Secondary endpoints included time to onset of action. The study concluded that FP/FORM was as effective as FP/SAL, with a least squares (LS) mean difference of -0.06 L between treatments. FP/FORM time to onset of action was more rapid than FP/SAL (hazard ratio: 1.64; 95% CI: 1.28, 2.10; p < 0.001; full analysis population; FP/FORM: n = 101; FP/SAL: n = 100) and FP/FORM and FP/SAL safety and tolerability profiles were similar1.
FLT3503 was a double-blind, double-dummy, multicentre, parallel-group study, with FP/FORM (500/20µg or 100/10 μg), FP+FORM (500μg + 24μg), or fluticasone propionate (FP) 500 μg alone (all twice daily). 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.
Secondary endpoints from this study showed that FP/FORM 500/20µg demonstrated superior efficacy to FP alone, with an increase from baseline in mean morning pre-dose FEV1 to 2 hours morning post-dose at Week 8 of 0.517 L (n = 154) and 0.396 L (n = 155), respectively (least squares [LS] mean of the treatment difference: 0.120 L; 95% CI: 0.011, 0.230; p = 0.032). FP/FORM 500/20 µg was more effective than FP/FORM 100/10 µg (n = 155), with an overall LS mean difference between treatments (from baseline; including all study visits) of 0.085 L for change in morning pre-dose FEV1 (95% CI: 0.003, 0.168; p = 0.043). Additionally, FP/FORM 500/20 µg showed superior efficacy to FP/FORM 100/10 µg and FP alone in multiple, clinically important secondary endpoints. Safety and tolerability profiles were similar across all groups2.
GPRD retrospective study compared the real-world effectiveness of FP/SAL via metered-dose inhaler (MDI) versus dry powder inhaler (DPI) in a UK primary care asthma population. The co-primary endpoints were composite proxy asthma control (no exacerbations or antibiotics for lower respiratory infections) and exacerbations. The study demonstrated that using logistic/poisson regression modelling, the odds of achieving asthma control were significantly lower and exacerbation rates significantly higher among DPI compared with MDI patients10.
*Includes the following EU countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, UK
References:
1. Bodzenta-Lukaszyk A, Dymek, Mansikka H. Fluticasone propionate/formoterol fumarate combination therapy is as effective as fluticasone propionate/salmeterol xinafoate, but has a more rapid onset of action in the treatment of asthma. Abstract presented at ERS, 18-22.09 2010 in Barcelona, Spain.
2. Bumbacea D, Pulka G, Dymek A et al. Fluticasone propionate/formoterol fumarate combination therapy is more effective than fluticasone propionate alone in the treatment of asthma. Abstract presented at ERS, 18-22.09 2010 in Barcelona, Spain.
3. Partridge MR, van der Molen T, Myrseth SE et al. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm Med 2006;6:13.
4. Cazzoletti L, Marcon A, Janson C et al. Asthma control in Europe: a real-world evaluation based on an international population-based study. J Allergy Clin Immunol 2007;120:1360–7.
5. Buhl R, Vogelmeier C. Budesonide/Formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma. Curr Med Res Opin 2007;23:1867–78.
6. IMS Health, UK; MIDAS database, accessed May 2010.
7. Berger WE. The use of inhaled formoterol in the treatment of asthma, Ann Allergy Asthma Immunol. 2006;97:24–33.
8. Prenner BM. Formoterol dry-powder inhaler for the treatment of asthma and chronic obstructive pulmonary disease. Expert Opin. Pharmacother. 2007; 8(17):3069-3084.
9. Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Res J 2009;18:243–9.
10. Price D, Ali M, Burden A et al. Device type and real-world effectiveness of combination therapy. Abstract presented at ERS, 18-22. 09 2010 in Barcelona, Spain.
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