Long-term safety and efficacy of a chlorofluorocarbon-free beclomethasone dipropionate extrafine aerosol

Background: Beclomethasone dipropionate (BDP) extrafine aerosol, a newly de veloped pressurized metered dose inhaler (pMDI) with a hydrofluoroalkane-13 4a (HFA) propellant (HFA-BDP; Qvar, 3M Pharmaceuticals, St. Paul, MN), has been shown to be effective in controlling asthma symptoms, at approximately half the daily dose of chlorofluorocarbon (CFC)-BDP. Objective: This study evaluated the long-term efficacy and safety of switch ing patients with asthma maintained on a stable dose of CFC-BDP pMDI to the rapy with HFA-BDP pMDI at approximately half their previous daily dose of C FC-EDP. Methods: This was an open-label, randomized, parallel-group multicenter tri al. Patients with at least a 6-month history of asthma whose symptoms were controlled on CFC-BDP, 400 to 1600 mug daily, during a 2-week run-in period were randomized in a 1:3 ratio to CFC-BDP at the same daily dose or HFA-BD P at approximately half the daily dose of CFC-BDP for 12 months. Results: A total of 473 patients were randomized: 354 to HFA-BDP, 119 to CF C-BDP. There were no statistically significant differences between groups i n mean change from baseline in morning (AM) peak expiratory flow rate or fo rced expiratory volume in one second throughout the study. There were no co nsistent differences between treatment groups in individual asthma symptoms or daily beta (2)-agonist use during the study. There was an increase in t he percentage of symptom-free days between baseline and month 12 in the HFA -BDP group (11.5%) and the CFC-BDP group (4.6%). No statistically significa nt differences in serum osteocalcin levels or adverse events were seen duri ng the study or in AM plasma cortisol levels at month 12. Conclusions: Asthma control was maintained in patients switched from a stab le dose of CFC-BDP (400 to 1600 mug daily) to HFA-BDP at approximately half the CFC-BDP dose (200 to 800 mug daily), and was maintained over the next 12 months. HFA-BDP demonstrated a similar safety profile to CFC-BDP; there were no differences between the agents with regard to systemic effects.