Inspiratory Flows and Volumes in Subjects with Cystic Fibrosis Using a New Dry Powder Inhaler Device
Mark R. Elkins1, Philip Robinson2, Sandra D. Anderson1, Clare P. Perry1, Evangelia Daviskas1, Brett Charlton*, 3
1 Royal Prince Alfred Hospital, Sydney, Australia
2 Murdock Children's Research Institute and University of Melbourne, Royal Children's Hospital, Melbourne, Australia
3 Pharmaxis Ltd, Sydney, Australia
Drug inhalation via a dry-powder inhaler (DPI) is a convenient, time efficient alternative to
nebulizers in the treatment of cystic fibrosis (CF). Efficient drug administration via DPIs depends on the device resistance
and adequate (≥ 45L/min) inspiratory flows and volumes generated by individuals. Dry-powder mannitol is delivered
using a RS01 breath-actuated device developed by Plastiape, for Pharmaxis. The study aim was to determine in vivo if CF
patients’ inspiratory flows and volumes are adequate to use the RS01 DPI device.
Materials and Methodology:
An open, non-interventional study; enrolled 25 CF subjects, aged ≥ 6 years with FEV1 ≥ 30
to < 90‰ predicted. Inspiratory flows and volumes were measured when subjects inhaled in a controlled manner through
the RS01 device in series with a spirometer.
The mean inspiratory volume (IV) of CF subjects was 1.83L ± 0.97. Their achieved mean ± SD peak inspiratory
flow (PIF) was 75.5 ± 27.2L/min. Twenty-three subjects (92%) achieved PIF of > 45L/min with the inhaler device;
eighteen of those subjects (78%) had a baseline FEV1 of > 1L.
Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder
mannitol in CF patients.
Keywords: : Clinical trials, cystic fibrosis, respiratory function tests, dry powder inhaler, high resistance inhaler, peak inspiratory flow..
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* Address correspondence to this author at Pharmaxis Ltd., 20 Rodborough Road, Frenchs Forest NSW 2086, Australia; Fax: +61 2 9451 3622; E-mail: firstname.lastname@example.org