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)
For
clinical inquiries, please contact:
Dominic
P. Coppolo, MBA, RRT, FAARC
Vice
President Clinical Strategy and Development
Monaghan
Medical Corporation
1-800-343-9071
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
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