Safety and Efficacy of HFA‐134a Beclomethasone Dipropionate Extra‐Fine Aerosol over Six Months

Abstract

OBJECTIVE: To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate (HFA-BDP) extra-fine aerosol 800 µg/day with chlorofluorocarbon (CFC)-BDP 1500 µg/day.DESIGN: Six-month, randomized, parallel-group, double-blind, double-dummy study.PATIENTS: Patients (n=141) with moderate to severe asthma adequately controlled by CFC-BDP 1000 µg/day to 2000 µg/day.INTERVENTIONS: Patients received CFC-BDP 1500 µg/day during a two-week run-in period and were then randomized to either HFA-BDP (n=70) or CFC-BDP (n=71).RESULTS: Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 (15% versus 25%, P=0.35). Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP (P=0.076); 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients (P=0.095).CONCLUSIONS: HFA-BDP 800 µg/day has a systemic adverse event profile comparable to that of CFC-BDP 1500 µg/day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 µg/day to HFA-BDP 800 µg/day.

Extrafine Versus Fine Inhaled Corticosteroids in Relation to Asthma Control: A Systematic Review and Meta-Analysis of Observational Real-Life Studies

“…(10;12;15-17) Randomised controlled trials (RCTs) comparing the short-term efficacy of efBDP and efCIC to that of conventional ICS found that the extra-fine formulation offered equivalent efficacy when administered at half the dose of conventional ICS. (18)(19)(20)(21) Indeed, a rigorous dose response study has confirmed that efBDP provides significantly greater effects on lung function than comparable doses of CFC-BDP (22) and the improvements in asthma symptoms and quality of life recorded in 6-and 12-month RCTs although not statistically significant tended to be better with efBDP than CFC-BDP at twice the dose, (23)(24)(25) suggesting that there may be clinically meaningful differences between the extra-fine particle and larger particle formulations.…”

Asthma control with extrafine‐particle hydrofluoroalkane–beclometasone vs. large‐particle chlorofluorocarbon–beclometasone: a real‐world observational study

“…Moreover, RCTs likely do not capture the effects of suboptimal adherence as well as of poor inhaler technique that are commonplace in realworld practice [16]. Nonetheless, in 6-month and 12month RCTs, improvements in asthma symptoms and quality of life tended to be better with EF HFA-BDP than CFC-BDP at twice the dose [17][18][19], suggesting that there may be clinically meaningful differences between the EFparticle and large-particle formulations.…”

Access to inhaled corticosteroids is key to improving quality of care for asthma in developing countries

“…HFA formulations of salbutamol have been judged comparable with those containing CFCs (48–51). However, HFA beclomethasone has proved effective and less toxic at lower doses: the dose equivalence between HFA‐beclomethasone and CFC‐beclomethasone is approximately 2 to 1 (52–59). Thus, the number of puffs per day for HFA‐beclomethasone (Fig.…”