Inspiratory Flows and Volumes in Subjects with Non-CF Bronchiectasis Using a New Dry Powder Inhaler Device



Mark R. Elkins1, Sandra D. Anderson1, Clare P. Perry1, Evangelia Daviskas1, Brett Charlton*, 2
1 Royal Prince Alfred Hospital, Sydney, Australia
2 Pharmaxis Ltd, Sydney, Australia


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© Elkins et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at Pharmaxis Ltd., 20 Rodborough Road, Frenchs Forest NSW 2086, Australia; Fax: +61 2 9451 3622; E-mail: brett.charlton@pharmaxis.com.au


Abstract

Introduction:

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.

Materials and Methodology:

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.

Conclusion:

Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder mannitol in non-CF bronchiectasis patients.

Keywords: : Bronchiectasis, clinical trials, respiratory function tests, dry powder inhaler, high resistance inhaler, peak inspiratory flow..