title: Inspiratory Flows and Volumes in Subjects with Non-CF Bronchiectasis Using a New Dry Powder Inhaler Device.
abstract: BACKGROUND
  Drug inhalation via a dry-powder inhaler (DPI) is a convenient, time efficient alternative to nebulizers in the treatment of cystic fibrosis (CF) or non-CF bronchiectasis. Efficient drug administration via DPIs depends on the device resistance and adequate (≥45L/min) inspiratory flows and volumes generated by individuals. Drypowder mannitol is delivered using a RS01 breath-actuated device developed by Plastiape, for Pharmaxis. The study aim was to determine in vivo if non-CF bronchiectasis patients' inspiratory flows and volumes are adequate to use the RS01 DPI device.
  
  
  METHODS
  An open, non-interventional study; enrolled 17 subjects with non-CF bronchiectasis, 18 to 80 years, with baseline FEV1 ≥1.0L and ≥50‰ predicted. Inspiratory flows and volumes were measured when subjects inhaled in a controlled manner through the RS01 device in series with a spirometer.
  
  
  RESULTS
  The mean inspiratory volume (IV) of non-CF bronchiectasis subjects was 2.08 ± 0.5L and achieved a mean PIF of 78.6 ± 11.2L/min with the inhaler device.
  
  
  CONCLUSIONS
  Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder mannitol in non-CF bronchiectasis patients.
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Elkins
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: Sandra D
authors.initials: SD
authors.lastname: Anderson
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: Clare P
authors.initials: CP
authors.lastname: Perry
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: Evangelia
authors.initials: E
authors.lastname: Daviskas
authors.affiliation: Pharmaxis Ltd, Sydney, Australia.
authors.forename: Brett
authors.initials: B
authors.lastname: Charlton
keywords: Bronchiectasis; clinical trials; dry powder inhaler; high resistance inhaler; peak inspiratory flow.; respiratory function tests