Pressurized Metered Dose Inhaler Delivery to Infants Via Valved Holding Chamber with Facemask: Not All Valved Holding Chambers Perform the Same

M. Nagel1, J. Suggett1 and A. Bracey2 1 Trudell Medical International, London, Canada. 2 Trudell Medical UK, Nottingham, United Kingdom

ADAM-III infant face on Rationale • an electret filter was located at the outlet of the model, support mount for adjustment Values of the Therapeutically Beneficial of facemask to face fit • Delivery of inhaled medication to an infant from a representing the carina Delivered Mass (µg) per Actuation Pressurized Metered Dose Inhaler (pMDI) via Valved • The mass of Ventolin was subsequently recovered from the 5.0 Actuate on Holding Chamber (VHC)-facemask is dependent upon the filter and assayed by HPLC to determine delivered mass 4.5 interaction between facemask and face of the patient Actuate on 4.0

• Using an anatomically accurate nasopharynx (ADAM-III) 3.5 AeroChamber Plus* Flow-Vu* infant model we report the findings of clinically appropriate Antistatic VHC with small facemask 3.0 testing from several VHC facemask products used to Trudell Medical International deliver Ventolin† 2.5

2.0

Tidal flow Able Spacer† 2 BabyHALER† Aerosol collection Inlet port with 1.5 METHODS filter at distal end of protection filter

Clement Clarke GlaxoSmithKline Inc. Delivered Mass (µg/actuation) nasopharynx to simulate for ASL test 1.0 • Each VHC (n = 5 per VHC type) was prepared to location of carina manufacturer instructions, then evaluated by 0.5 simulator (ASL 5000), mimicking tidal breathing with the 0.0 AeroChamber Plus* Able Spacer† 2 BabyHALER† Compact Space Volumatic† † † Compact Space Chamber Plus Volumatic † following parameters Flow-Vu* AVHC Wash, no rinse Wash, rinse Chamber Plus Out of package Antistatic VHC GlaxoSmithKline Inc. RESULTS Mean ± SD Out of package Out of package • (Vt) = 50 mL Medical Developments International Ltd. DM Valved Holding Chamber pMDI Actuation • I:E ratio = 1:3 (µg/actuation) ADAM-III obligate nasal-breathing infant face model On Inhalation 4.5 ± 2.2 CONCLUSIONS • rate = 30 BPM including anatomically correct nasopharynx AeroChamber Plus* Flow-Vu* AVHC out of package On Exhalation 4.5 ± 1.3 † • delivered mass ex AeroChamber Plus* Flow-Vu* AVHC • 5 doses of Ventolin were delivered, timing each actuation † On Inhalation 1.0 ± 0.6 Able Spacer 2 group was significantly greater than the other VHC devices to coincide with wash, no rinse On Exhalation 0.7 ± 0.3 (unpaired t-test, p<0.001) • inhalation (coordinated) BabyHALER† On Inhalation 0.0 ± 0.0 wash, rinse On Exhalation 0.0 ± 0.0 • potential reasons for this could relate to mask leakage, VHC • exhalation (uncoordinated) Model Naso-Pharyngeal Airway † On Inhalation 0.3 ± 0.3 Courtesy: W. H. Finlay Compact Space Chamber Plus design and VHC material out of package On Exhalation 0.4 ± 0.3 • Clinicians should be aware that the delivered mass from Volumatic† On Inhalation 0.5 ± 0.1 Front View Infant Model out of package On Exhalation 0.5 ± 0.1 VHCs can differ significantly, which may have a clinical impact

ERS International Congress Milan, Italy Excellence By Design September 9 – 13, 2017

MD-802A-0717. * trade-marks and registered trade-marks of Trudell Medical International. † trade-marks and registered trade-marks of their respective companies. Copyright © Trudell Medical International 2017.