title: Beclometasone dipropionate extrafine aerosol versus fluticasone propionate in children with asthma.
abstract: Beclometasone dipropionate (BDP) extrafine is a hydrofluoroalkane-based, chlorofluorocarbon (CFC)-free inhalation aerosol. This study was conducted to determine whether BDP extrafine and CFC-fluticasone proprionate (FP) aerosols were equivalent in terms of efficacy and tolerability in children with symptomatic mild-to-moderate asthma. Male and female patients (aged 5-12 yr) with an asthma diagnosis for > or =3 months, peak expiratory flow (PEF) > or =60% of predicted normal and suboptimal asthma control were randomised to double-blind treatment with BDP extrafine 200 microg day(-1) (n=139) or CFC-FP 200 microg day(-1) (n=141) for up to 18 weeks. After 6 and 12 weeks, study medication was 'stepped down' to 100 and 50 microg day(-1), respectively, if patients had achieved good asthma control. Patients with poor asthma control discontinued from the study and those with intermediate control continued in the study but did not undergo a dose reduction. The estimated treatment difference in morning PEF% predicted at 6 weeks was -1.9% (90% CI -4.9, 1.0). There was a trend towards a greater increase in forced vital capacity (% predicted) in the BDP extrafine group (5.3 versus 0.4%; p=0.084). A 'step-down' in therapy to 100 microg day(-1) was possible in 36% and 42% of patients in the BDP extrafine and CFC-FP groups, respectively, at 6 weeks. Both drugs were well tolerated. BDP extrafine and CFC-FP aerosols were equally effective at improving asthma control in children with mild-to-moderate asthma at the same daily dose.
authors.affiliation: Emma Children's Hospital AMC, Amsterdam, The Netherlands. w.m.vanaalderen@amc.uva.nl
authors.forename: W M C
authors.initials: WM
authors.lastname: van Aalderen
authors.forename: D
authors.initials: D
authors.lastname: Price
authors.forename: F M
authors.initials: FM
authors.lastname: De Baets
authors.forename: J
authors.initials: J
authors.lastname: Price
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000009:adverse effects / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D011788:Quality of Life; D015656:Respiratory Mechanics / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D000068298:Fluticasone; D001507:Beclomethasone