Extrafine beclomethasone dipropionate/formoterol hydrofluoroalkane-propelled inhaler in asthma.

The fixed combination of beclomethasone and formoterol (BDP/F) is an extrafine hydrofluoroalkane-propelled formulation characterized by a small particle size and high particle deposition in the lower airways. The product is manufactured using a specific technology known as Modulite((R)), the advantages of which include a stable and uniform dose delivery and flexibility to tailor particle size. The high fraction of drug available for lung deposition and the resulting low fraction remaining in the upper airways account for a high efficacy coupled with a low systemic bioavailability, therefore making this combination competitive compared with other inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) fixed combinations currently available. A 6-month study comparing BDP/F fixed combination with BDP and formoterol administered via separate inhalers showed a comparable efficacy on lung function and a greater efficacy in favor of the BDP/F fixed combination in terms of improvements in symptom scores and asthma control. Comparative studies in moderate-to-severe asthmatics have shown that the BDP/F combination displays a comparable efficacy to that of ICS/LABA combinations across the different asthma outcomes measured. The smaller particle size of this BDP/F combination in comparison with other ICS/LABA combinations makes it potentially more effective on small airways, a specific target for asthma treatment. This should be confirmed by specifically designed studies. Future development of this combination will include the evaluation of efficacy in maintaining asthma control using a step-down approach and the assessment of its use as maintenance and reliever therapy, since formoterol has already been shown to be an effective reliever medication in asthma in another inhaler containing budesonide/formoterol.