, Volume 66, Issue 11, pp 1475-1483
Date: 12 Sep 2012

Beclometasone Dipropionate/Formoterol

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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) 100μg/6μg. Each actuation of the BDP/formoterol HFA pMDI 100μg/6μg delivers 86.4μg of BDP and 5μg 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 200μg/12μg per day or 400μg/ 24μg per day administered by the HFA pMDI was generally well tolerated. Moreover, a single high dose of BDP/formoterol (1000μg/60μg) was generally well tolerated in patients with asthma.