Beclometasone Dipropionate/Formoterol in an HFA-Propelled Pressurised Metered-Dose Inhaler

Excerpt

Combination therapy with inhaled corticosteroids and long-acting β₂-agonists has become established for the treatment of patients with symptomatic, moderately severe asthma. The combinations currently available are fluticasone and salmeterol (Seretide®), available as pressurised metered-dose inhalers (pMDI) or powder device inhalers (PDI), and budesonide and formoterol (Symbicort®), available as PDI. The initial work that established the efficacy of combination therapy used the addition of salmeterol to beclomethasone dipropionate (BDP) in order to demonstrate better asthma control in patients taking low-dose BDP compared with patients receiving a double dose of BDP. The combination of BDP with formoterol is currently being developed. The novel feature of the BDP/formoterol formulation discussed in the preceding review is the use of a technology termed Modulite®, which allows for greater uniformity of the delivered dose with a fine particle distribution that increases penetration and the amount of drug delivered from a hydroflouroalkane (HFA) pMDI. This is rendered possible by use of an ethanol co-solvent. This technology has been applied to the delivery of BDP, budesonide and formoterol preparations, which are licensed in several countries. Studies of the HFA pMDI BDP/formoterol combination show its noninferiority in various aspects of asthma control compared with fluticasone/salmeterol or budesonide/formoterol. These studies have used a 1 : 1 corticosteroid equivalence of BDP HFA pMDI to fluticasone pMDI, a 1 : 2 equivalence of BDP HFA pMDI to budesonide in dry powder inhaler and to BDP CFC pMDI. No studies on exacerbations as primary endpoint have been done, but there are ongoing phase III studies. This new combination therapy for asthma would be useful to have on the market and is likely to be competitively priced. It would be important to know whether this new combination does have similar effects in reducing exacerbation rates as has been shown with the formoterol/budesonide PDI and whether patients with more severe asthma also respond well to this new combination. …