title: Efficacy of chlorofluorocarbon-free beclomethasone dipropionate 400 micrograms day-1 delivered as an extrafine aerosol in adults with moderate asthma.
abstract: Beclomethasone dipropionate (BDP) has been reformulated in a chlorofluorocarbon-free propellant, hydrofluoroalkane-134a (HFA), resulting in an extrafine aerosol which gives improved drug delivery to the airways. The objective of this 6 week, placebo-controlled study was to evaluate the clinical efficacy of HFA-BDP 400 micrograms day-1 in 256 adult patients with moderate asthma. This is a lower daily dose than that recommended for existing BDP inhalers in current treatment guidelines for moderate asthma (NIH publication 95-3659). Another objective was to evaluate whether delivering the 400 micrograms dose as four actuations of 50 micrograms twice daily (HFA-BDP 50 micrograms) provided equivalent asthma control to delivering the dose as two actuations of 100 micrograms twice daily (HFA-BDP 100 micrograms) without the use of a spacer or holding chamber. Both active treatments produced a significant change from baseline in morning peak expiratory flow (PEF), which was significantly larger than that in the placebo group (P < or = 0.017) throughout the study. The mean changes from baseline in morning PEF at weeks 5-6 were 47.0 l min-1 in the combined HFA-BDP group and 16.5 l min-1 in the HFA-placebo group. The two dose strengths were statistically equivalent (P = 0.017 for equivalence testing). The active treatments also produced significant improvements compared with placebo in evening PEF, forced expiratory volume in the first second, forced expiratory flow over 25-75% of vital capacity, sleep disturbance scores and daily beta-agonist use. The study medication was well tolerated, with a low incidence of adverse events. The results from this study demonstrate that a daily dose of 400 micrograms HFA-BDP (given in 50 micrograms and 100 micrograms strengths) provides dose proportionality and effective control in patients with moderate asthma.
authors.affiliation: Abteilung Pneumologie, Medizinische Universitätsklinik, Freiburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Matthys
authors.forename: D
authors.initials: D
authors.lastname: Nowak
authors.forename: S
authors.initials: S
authors.lastname: Hader
authors.forename: G
authors.initials: G
authors.lastname: Kunkel
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000335:Aerosol Propellants; D000336:Aerosols; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008297:Male; D010316:Particle Size; D005466:Fluorocarbons
chemical_list: D000335:Aerosol Propellants; D000336:Aerosols; D000893:Anti-Inflammatory Agents; D001507:Beclomethasone; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons