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New Published Evidence Reinforces the Importance of Device Choice in Asthma Control

02-01-2018 10:56 AM CET | Health & Medicine

Press release from: Monaghan Medical Corporation

/ PR Agency: Star One PR
New Published Evidence Reinforces the Importance of Device

Two new publications build on previous evidence that not all devices are equally effective in delivering asthma control.

Plattsburgh, NY, USA -- A recent article in Pulmonary Pharmacology and Physiology[1] provides in vitro evidence that the AEROCHAMBER PLUS® FLOW-VU® valved holding chamber (or spacer) delivers aerosolized drug more effectively than other chambers, a view further supported in a new literature review published in Therapeutic Advances in Respiratory Disease.[2]

The use of spacers with Metered Dose Inhalers (MDIs) has become firmly established in the management of asthma and COPD, with guidelines such as the Global Initiative for Asthma (GINA)[3] recommending their use to reduce oropharyngeal deposition of drug and counter the common problem of poor inhaler technique. What is not established, however, is whether there are any meaningful differences between the devices. While GINA guidelines do indicate that not all are the same - a view echoed by the European Medicines Agency (EMA) recommendations,[4] which state that data for MDIs should be generated with a 'specific named spacer' - this view is not expressed in all guidelines. Two recent publications set out to address the impact of spacer design on drug delivery performance and look at potential implications for clinical use.

Four similarly sized chambers were compared 'out of the box' in terms of statistical equivalence with the gold standard AEROCHAMBER PLUS® chamber with respect to retention of drug particles within the device and the aerodynamic particle size distribution of the drug particles delivered. Only the AEROCHAMBER PLUS® FLOW-VU® chamber (Monaghan Medical Corporation) demonstrated an equivalent profile of dose retention and delivery versus the reference chamber. The Compact Space Chamber Plus† (Medical Developments), the OptiChamber Diamond† (Philips Respironics, Inc), and InspiraChamber† (Lupin Pharmaceuticals, Inc) devices all retained approximately twice as much drug, delivering around half the dose and showing non-equivalent performance compared with the AEROCHAMBER PLUS® FLOW-VU® chamber and reference chamber (pretreated AEROCHAMBER PLUS® chamber).

Lead author, Dr Sanjeeva Dissanayake, has recently published a literature review in Therapeutic Advances in Respiratory Disease, which provides further support for these findings. In considering the important attributes of such delivery devices, the review notes a shift in emphasis from chamber size and shape to other aspects, such as consistency of drug delivery, static charge reduction, valve performance, and factors optimizing facemask effectiveness (such as flexibility and seal). Despite the general lack of published clinical studies that confirm the therapeutic benefits of such differences, the AEROCHAMBER® 'family' of chambers has amassed an impressive body of clinical evidence. Most recently, a real-world database study[5] has demonstrated improved clinical benefits and reduced resource utilization use with the AEROCHAMBER PLUS® FLOW-VU® chamber versus other chambers in patients with asthma. A study specifically looking at the FLOW-VU® inhalation indicator has also shown benefits for carer confidence in dose delivery, and improved care-giver preference and quality of life.[6]

Dr Dissanayake commented, 'The in vitro equivalence study results and the literature review findings provide strong support for the EMA guideline recommendations that data for MDIs should be generated with specific spacer devices, and further reinforce the view that superficially similar chambers should not automatically be considered to be interchangeable - even if superficially similar'.

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AEROECLIPSE® II BAN, AEROCHAMBER PLUS® aVHC and the AEROBIKA® device exclusively in the United States. MMC's strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers. (http://www.monaghanmed.com)

About AEROCHAMBER® brand valved holding chambers (VHC), including the AEROCHAMBER PLUS® FLOW-VU® AVHC
Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their MDI medications correctly, the AEROCHAMBER® brand of chamber has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and healthcare system savings.

• The AEROCHAMBER® brand is the global leader of chambers, with safety and efficacy validated in numerous third party clinical evaluations amongst various patient populations; it is the chamber most recommended by leading MDI pharmaceutical companies.[7]

• AEROCHAMBER PLUS® FLOW-VU® chamber is designed to deliver the intended prescribed dose via the MDI, similar to using an MDI with perfect technique. An additional feature is the incorporation of the FLOW-VU® inspiratory indicator for the care-giver to observe effective inhalation. The FLOW-VU® indicator provides real time feedback confirming an effective inhalation and ensures that there are no leakages of ambient air into the space between facemask and face, that could prevent medication delivery altogether. (http://www.monaghanmed.com)

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. † trademarks of respective company. © 2018 Monaghan Medical Corporation.

1. Dissanayake S, Nagel M, Falaschetti E, Suggett J. Are valved holding chambers (VHCs) interchangeable? An in vitro evaluation of VHC equivalence. Pulmonary Pharmacology & Therapeutics. 2018; 48:179-184 http://doi.org/10.1016/j.pupt.2017.10.005
2. Dissanayake S, Suggett J. A review of the in-vitro and in-vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu anti-static VHC. Therapeutic Advances in Respiratory Disease. 2018; 12. http://doi.org/10.1177/1753465817751346
3. Global Initiative for Asthma: Global strategy for asthma management and prevention, 2017 Available from: www.ginaasthma.org. 2017.
4. Dissanayake S. Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products. Respiratory Drug Delivery 2010. Vol 12010:293-304.
5. Burudpakdee, C., Kushnarev, V., Coppolo, D. et al. Pulmonary Therapy. 2017; 3(2):283-96. http://doi.org/10.1007/s41030-017-0047-1
6. Ammari WG, Toor S, Chetcuti P, Stephenson J, Chrystyn H. Evaluation of asthma control, parents' quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma. The Journal of Asthma: Official journal of the Association for the Care of Asthma. 2015;52(3):301-307.
7. AeroChamber brand of holding chambers. Study Summary (September 2017). Available from: http://www.trudellmed.com/aerochamber-study-summary

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
5 Latour Ave # 1600, Plattsburgh, NY 12901
1-800-343-9071

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