title: Variability of aerosol delivery via spacer devices in young asthmatic children in daily life.
abstract: Pressurized metered dose inhalers (pMDI) are widely used together with spacers for the treatment of asthma in children. However, the variability of daily medication dose for pMDI/spacer combinations is not known. Electrostatic charge is a potential source of dose variability. Metal spacers have no static charge. This study assessed and compared within-subject variability of aerosol delivery of metal and plastic spacers. This was a randomized, crossover study in children with stable asthma aged 1-4 (group I, n=17) and 5-8 (group II, n=16) yrs. In both groups the amount of drug delivered to the mouth by a metal spacer (Nebuchamber) and one of two plastic (polycarbonate) spacers, i.e. Babyhaler in group I and Volumatic in group II was measured. The metal and plastic spacers were tested at home in a randomized order for 7 days each, using budesonide (200 microg b.i.d.). Aerosol was collected on a filter positioned between spacer and facemask or mouth. Budesonide on the filter was assessed by high performance liquid chromatography. The mean filter dose for each child (mean+/-SD) during the 7 days was expressed as a percentage of the nominal dose. Within-subject variability was expressed as coefficient of variation (CV). Mean filter dose in group I was 41.7+/-10.1% for Nebuchamber and 26.0+/-4.0% for Babyhaler (p<0.001). Mean filter dose in group II was 50.2+/-9.2% for Nebuchamber and 19.4+/-7.2% for Volumatic (p<0.001). Mean CV in group I was 34% for Nebuchamber and 37% for Babyhaler (p=0.44). Mean CV in group II was 23% for Nebuchamber and 34% for Volumatic (p=0.003). There was substantial within-subject dose variability in aerosol delivery in children using a pMDI/spacer at home. This variability was lower for the metal than for the plastic spacer in children 5-8 yrs of age. The dose delivered to the mouth was about two-fold higher for the metal than the plastic spacer independent of age.
authors.affiliation: Dept of Paediatrics, Sophia Children's Hospital, and Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: H M
authors.initials: HM
authors.lastname: Janssens
authors.forename: S G
authors.initials: SG
authors.lastname: Devadason
authors.forename: W C
authors.initials: WC
authors.lastname: Hop
authors.forename: P N
authors.initials: PN
authors.lastname: LeSouëf
authors.forename: J C
authors.initials: JC
authors.lastname: De Jongste
authors.forename: H A
authors.initials: HA
authors.lastname: Tiddens
mesh_terms: D000336:Aerosols / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D016503:Drug Delivery Systems; D005374:Filtration / Q000295:instrumentation; D006801:Humans; D007223:Infant; D008397:Masks; D009330:Nebulizers and Vaporizers
chemical_list: D000336:Aerosols; D001993:Bronchodilator Agents; D019819:Budesonide