Beclometasone dipropionate/formoterol: in an HFA-propelled pressurised metered-dose inhaler

Abstract

A hydrofluoroalkane (HFA)-propelled pressurised metered-dose inhaler (pMDI) has been developed (using Modulite technology) for a new fixed combination of beclometasone dipropionate/formoterol fumarate (BDP/formoterol) 100 microg/6 microg. Each actuation of the BDP/formoterol HFA pMDI 100 microg/6 microg delivers 86.4 microg of BDP and 5 microg of formoterol. BDP/formoterol HFA pMDI was associated with significantly higher morning peak expiratory flow (PEF) values than BDP administered alone via a chlorofluorocarbon (CFC) pMDI (including when BDP was administered at a higher dosage) in well designed trials in adults with mild to moderate or moderate to severe asthma. In terms of morning PEF values, BDP/formoterol HFA pMDI was noninferior to BDP plus formoterol administered via separate inhalers in well designed trials in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was noninferior to fixed-combination budesonide/formoterol (the daily dosage of BDP was half that of budesonide) in terms of lung function, asthma symptoms and use of rescue medications in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was also noninferior to, and had a faster onset of bronchodilation than, fixed-combination fluticasone propionate/salmeterol. BDP/formoterol 200 microg/12 microg per day or 400 microg/24 microg per day administered by the HFA pMDI was generally well tolerated. Moreover, a single high dose of BDP/formoterol (1000 microg/60 microg) was generally well tolerated in patients with asthma.