Clinical studies in asthmatics with a new non-extra fine HFA formulation of beclometasone dipropionate (BDP Modulite)

The main objective of the clinical development programme for BDP Modulite, a new non-extra fine formulation of beclometasone dipropionate (BDP) in hydrofluoroalkane (HFA), has been to demonstrate therapeutic equivalence compared with standard BDP chlorofluorocarbon (CFC) products at the recommended posology (delivered dose and patient population). A total of 1158 asthmatic patients were included in five clinical studies and 658 patients were treated with BDP Modulite. Four studies were undertaken in mild or moderate-to-severe asthmatic adults, while one study was carried out in children. The duration of treatment was 12 weeks in three studies and 6 weeks in the other two studies. A range of doses of BDP Modulite from 200 micrograms bid up to 1500 micrograms bid was evaluated against CFC comparators. The primary efficacy variable in all studies was morning PEFR while secondary variables included other lung function parameters, symptom scores and salbutamol use. All studies demonstrated equivalence of efficacy for morning PEFR for BDP Modulite versus BDP-CFC when compared on a microgram for microgram basis. The secondary outcome variables also consistently support similar efficacy of the two products. The safety and tolerability profile for BDP Modulite was similar to BDP-CFC; the incidence of adverse events was comparable between treatments and plasma and urinary cortisol were generally unchanged in patients receiving 1000 micrograms day-1 for 6-12 weeks. In conclusion, the results of the clinical studies with BDP Modulite show that this new HFA formulation allows a seamless transition to CFC-free BDP, thus simplifying the changeover.