Inspiratory Flow Profiles for Dispersion of PulmoSphere® Particles1
In a clinical study, patients with moderate to severe disease
(6 years and older) were able to receive medication via the Podhaler device2
Older patients with significant disease progression and associated decreases in forced expiratory volume in 1 second (FEV1), and younger patients (aged >6 years) with inhaled volumes <1 L, were able to generate the inspiratory flow rates and volumes required to receive their medication when following the Instructions for Use; however, no pediatric patients aged 6 to 10 years with FEV1 <40% predicted were evaluated.2
*This study explored inspiratory variables of 96 patients with CF aged ≥6 years with varying degrees of lung disease while inhaling through mouthpieces with resistance that simulated dry-powder inhaler devices. Enrolled patients were aged 6 to 53 years with FEV1 19% to 126% predicted. TOBI® Podhaler® is indicated for patients with an FEV1 25% to 80% predicted.1-3
†A flow rate of 40 L/min represents a flow rate more than 2 standard deviations below the mean peak inspiratory flow rates measured for pediatric patients in the study.4
1. TOBI Podhaler [Prescribing Information, 2020]
2. Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere™ Technology. J Aerosol Med Pulm Drug Deliv. 2011;24(4):175-182.
3. Danforth P. Miller, Trixie Tan, Thomas E. Tarara, John Nakamura, Richard J. Malcolmson, and Jeﬀry G. Weers. Physical Characterization of Tobramycin Inhalation Powder: I. Rational Design of a Stable Engineered-Particle Formulation for Delivery to the Lungs. Mol. Pharmaceutics 2015, 12, 2582−2593.
4. Tiddens HA, Geller DE, Challoner P, et al. Effect of dry powder inhaler resistance on the inspiratory flow rates and volumes of cystic fibrosis patients of six years and older. J Aerosol Med. 2006;19(4):456-465.