Real-world retrospective study demonstrates device choice impacts asthma control

06 February 2018. A real-world study in more than 18,000 patients has demonstrated superior asthma control with the AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) compared with other chambers.[1]

According to this new retrospective study, published in Pulmonary Therapy, the AeroChamber Plus* Flow-Vu* Anti-Static VHC was associated with a significant delay in time to first exacerbation (p=0.0005) and a significant 13% reduction in Emergency Room/Accident and Emergency (ER/A&E) visits (p=0.0167) compared with control, non-anti-static chambers. There was also a strong trend towards a reduction in hospitalisations (p=0.0702). The AeroChamber Plus* Flow-Vu*Anti-Static VHC was made available on prescription in the UK in November 2017.

The study results for the 8,586 patients who could be followed-up for at least 12 months show:

The AeroChamber Plus* Flow-Vu* Anti-Static VHC is designed with user-friendly features to improve patients’ inhaler technique[2] and to ensure delivery of the intended dose of medication, leading to real clinical benefits for patients. The chamber is made from an antistatic polymer which prevents electrostatic charge-related loss of medication to the walls of the chamber and allows it to be used straight out of the packet without pre-treatment or priming.[3]^,[4] This device has a dedicated inhalation indicator (branded as the Flow-Vu* Inhalation Indicator). This feedback tool gives caregivers the ability to confirm that there is a proper facemask seal, which helps the caregiver to coordinate actuation of the pressurised metered-dose inhaler (pMDI) with inhalation and to count breaths, thus ensuring the patient gets the intended dose of their prescribed medications.

“At Trudell Medical UK Limited we aim to bring innovative solutions to real-life problems, unlocking improved outcomes for respiratory patients. The current NHS crisis is exacerbated by patients presenting to A&E with respiratory problems that often get worse in winter. Our new AeroChamber Plus* Flow-Vu* Anti-Static VHC may reduce some of the 121,000 A&E attendances made by asthma patients every year in the UK,” said Dr Alan Clark, Regional Head, Europe, Trudell Medical UK Limited. “A 13% reduction may mean 15,730 fewer visits to A&E by asthma patients each year. Furthermore, if all people with asthma currently using a pMDI plus VHC in the UK were switched to the AeroChamber Plus* Flow-Vu* Anti-Static VHC, our budget impact model shows that in one year the UK health system could reallocate £7.2m of healthcare resources to other areas of need due to reduced demand by patients with asthma.[5]”

Innovation in respiratory drug delivery is needed in the UK. The National Review of Asthma Deaths in the UK reported that misunderstanding and misuse of inhalers may have contributed to a significant number of the 195 asthma deaths reported during 2012.[6] Despite effective medication being available, 82% of asthma patients report being poorly controlled.[7]

“It’s great to see a company take a very good product and make it even better by putting the patient at the centre of the development process and using their feedback to make it easier to use. The data strongly suggest that by improving delivery of medication to the lungs the AeroChamber Plus* Flow-Vu* Anti-Static VHC can demonstrably reduce use of hospital resources,” said Dr Dermot Ryan, President of the Respiratory Effectiveness Group and former primary care physician.

For those with asthma, particularly children, the choice of VHC – sometimes referred to as spacer/holding chamber devices[8]^{,[9],[10],[11]} – to help deliver medication is an important consideration. It is also evident that performance differences exist between VHCs. Thus, chamber shape, volume and length, the use of conventional statically charged versus anti-static materials, inhalation valve function, and facemask design have all been variously implicated in performance differences between different spacers/VHCs.^3,[12]^,[13] Therefore, it is important to note that not all spacers/VHCs perform equally well.^[14]

Currently there are a small number of VHC brands available that are made of clear antistatic polymers. A new in vitro evaluation of VHC equivalence published this month in Pulmonary Pharmacology and Therapeutics¹² provides evidence that the AeroChamber Plus* Flow-Vu* Anti-Static VHC delivers aerosolised drug more effectively than a number of other antistatic VHCs. Four similarly sized antistatic VHCs were compared ‘out of the box’ with a pre-treated reference chamber (AeroChamber Plus* VHC) with respect to retention of drug particles within the device and respirable dose fraction delivered. Only the AeroChamber Plus* Flow-Vu* Anti-Static VHC demonstrated a similar profile of dose retention and delivery versus the reference chamber. The following antistatic VHCs:  Compact Space Chamber Plus^® (Medical Developments); the OptiChamber Diamond^TM (Philips Respironics, Inc); and InspiraChamber^TM (Lupin Pharmaceuticals, Inc; not available in the UK); all retained approximately twice as much drug, delivering around half the dose compared with theAeroChamber Plus* Flow-Vu* Anti-Static VHC and reference chamber.

‘This in vitro equivalence study shows that even superficially similar antistatic chambers deliver different amounts of medication, and reinforces the view that chambers, including newer antistatic chambers, should not automatically be considered interchangeable,’ said Dr Sanjeeva Dissanayake, lead author of equivalence study.

Asthma is a common respiratory condition which affects 5.4 million people in the UK.⁷ Asthma is estimated to cost the UK ≥£1.1 billion each year.[15] Inhalation is the recommended route of administration for asthma medications; it provides direct targeting of drug to the lungs, and side effects are reduced compared with systemic medications. Inhaled corticosteroids (ICS) and bronchodilators administered by pMDIs are the mainstay of long-term asthma treatment, the goals of which are to improve symptoms and prevent the occurrence of exacerbations.^[16] Unfortunately, poor inhaler technique is common, resulting in less of the delivered drug reaching the lungs, with much of it being deposited on the back of the throat and then swallowed.^[17] Inhaler technique has not improved over the past 40 years, with the most frequent pMDI errors being in coordination, speed and/or depth of inspiration and no post-inhalation breath-hold.[18]

The Global Initiative for Asthma’s report recommends the use of spacers to improve pMDI drug delivery.¹⁶ In the UK, a joint Scottish Intercollegiate Guidelines Network (SIGN) / British Thoracic Society (BTS) guideline on the management of asthma recommends a pMDI and a spacer as the preferred method of delivery for children.¹⁹ They advise a facemask for young children then a mouthpiece when the child is old enough.^[19]  In addition, the National Institute for Health and Care Excellence (NICE) guidance on inhaler devices for routine treatment of chronic asthma in older children recommends a pMDI with an appropriate spacer as first choice for those aged 5-15.[20] The SIGN/BTS guideline also recommends a spacer for adults receiving high doses of inhaled corticosteroid.¹⁹

Studies indicate that patients who use a VHC with their pMDI have better asthma control.^[21] Chambers were designed to hold the aerosol in the chamber until the patient is ready to inhale, which reduces the need for good coordination between inhalation and inhaler actuation, and to reduce the oropharyngeal deposition^[22]  meaning the drug gets into the patient’s lungs. Effectiveness of these devices can be adversely affected by the design, including the chamber electrostatic charge, a commonly reported cause of inconsistent medication delivery.^[23]

Real-world study co-author, Dr Jason Suggett (Group Director of Global Science and Technology, Trudell Medical International) said that the study also further supports the fact that chambers are not interchangeable. “The European Medicines Agency recommended in 2009 that development of a pMDI should include the testing of at least one specific named chamber, and that any substitution must be supported by appropriate in vitro or clinical data demonstrating equivalence”, he commented. “We presented laboratory data at the recentRespiratory Drug Delivery Europe meeting¹⁴ that confirmed that not all chambers perform equally well with the same pMDI, which underlines the importance of recognising the impact and potential risks of substituting one device for another.”

About Trudell Medical UK Limited (TM-UK)

TM-UK is committed to enhancing the quality of life for people of all ages with respiratory conditions. We and our affiliate, Trudell Medical International (“TMI”), are family-owned healthcare companies. TMI designs, develops and manufactures a wide range of high quality, innovative medical devices and is home to a global Aerosol Lab and Research Centre. Several of the TMI medical devices that TM-UK sells are available to patients in over 110 countries worldwide.

The AeroChamber* brand of Valved Holding Chambers is made available in the UK by TM-UK. Their efficacy has been validated in numerous peer-reviewed publications.

About AeroChamber^* brand Valved Holding Chambers (VHC), including the AeroChamber Plus^* Flow-Vu^* Anti-Static VHC

Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their pMDI medications correctly, the AeroChamber* brand of VHCs has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and provide healthcare system savings.

• AeroChamber Plus* is the global leading VHC brand, with safety and efficacy validated in numerous third party clinical evaluations amongst various patient populations. TheAeroChamber Plus* brand of VHCs is the most widely prescribed VHCs in the UK.[24]

• AeroChamber Plus* Flow-Vu* is an anti-static VHC designed to deliver the intended prescribed dose via the pMDI, similar to using a pMDI alone with perfect technique. An additional feature is the incorporation of the Flow-Vu* Inhalation Indicator for the caregiver to observe effective inhalation. A recent study showed that caregiver quality of life improved almost four-fold when using the AeroChamber Plus* VHC with the Flow-Vu* Inhalation Indicator versus the same VHC without the indicator.[25] The Flow-Vu* Inhalation Indicator provides real time feedback confirming effective inhalation and minimising the incidence of ambient air leakages into the space between facemask and face that could impair medication delivery.
• The range of AeroChamber Plus^* Flow-Vu^* Anti-Static VHCs were launched in the UK in November 2017. www.aerochamber.co.uk

For clinical inquiries, please contact:
Jason Suggett PhD, BPharm, MBA, MRPharmS
Group Director of Global Science and Technology, Trudell Medical International

For media enquries please contact:
Lorraine Walters (LWalters@saycomms.co.uk) or Jan Petherick (jpetherick@saycomms.co.uk) on +44 (0)20 8971 6400.

* trade-marks and registered trade-marks of Trudell Medical International © TMI 2017. All rights reserved.

References

^[1] Burudpakdee C, et al. A retrospective study of the effectiveness of the AeroChamber Plus^* Flow-Vu^* Antistatic Valved Holding Chamber for asthma control. Pulmonary Therapy. 2017; 3: 283-296 https://link.springer.com/content/pdf/10.1007%2Fs41030-017-0047-1.pdf  Accessed January 2018

^[2] Mitchel JP, et al. The Attributes of an Ideal Universal Valved Holding Chamber for Use with Pressurized Metered Dose Inhalers. Presented at Respiratory Drug Delivery Europe, France, 5–8 May 2015.

^[3] Suggett JA, et al. Clinically appropriate testing of different valved holding chamber – facemask combinations investigating delivered mass to carina for a widely prescribed inhaled corticosteroid delivered by pressurized metered-dose inhaler. Presented at Drug Delivery to the Lungs, Scotland, 9–11 December 2015.

^[4] Suggett JA, et al. Preparation of valved holding chambers before use can have a significant influence on subsequent medication delivery efficiency: a study with pressurized metered dose inhaler-delivered fluticasone propionate. Presented at Respiratory Drug Delivery Europe, France, 25–28 April 2017.

^[5] Trudell Medical UK Ltd: Budget Impact Model (Data on file)

^[6] Royal College of Physicians. Why asthma still kills: The National Review of Asthma Deaths (NRAD) confidential enquiry report. London: RCP, 2014.

^[7] Annual Asthma Survey 2016 report. Available from https://www.asthma.org.uk/globalassets/get-involved/external-affairs-campaigns/publications/annual-asthma-care-survey/annualasthmasurvey2016final.pdf. Asthma UK. Accessed January 2018

^[8] Lavorini F. The challenge of delivering therapeutic aerosols to asthma patients. ISRN Allergy 2013;2013:ID 102418.

[9] National Health Service England and Wales. Electronic Drug Tariff January 2018.  Part IX Appliances: Spacer/Holding Chamber Devices, Page 445. Available from:https://www.nhsbsa.nhs.uk/sites/default/files/2017-12/January%202018.pdf Accessed January 2018.

^[10] ISD Scotland. Scottish Drug Tariff January 2018. Part 3, Appliances: Spacer/Holding Chamber Devices, Page 271. Available from: http://www.isdscotland.org/Health-topics/Prescribing-and-Medicines/Scottish-Drug-Tariff/Docs/Jan-2018/2018-01-SDT-PART-3.pdf Accessed January 2018.

^[11] Health and Personal Services for Northern Ireland.  Drug Tariff January 2018.  Part III, Appliances: Spacer/Holding Chamber Devices, Page 136. Available from:http://www.hscbusiness.hscni.net/pdf/DT%20Full%20January%202018.pdf Accessed January 2018.

[12] 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;48:179–84.

^[13] Bracey A et al. Assessing Different Valved Holding Chambers with Facemask for Delivered Mass to Carina with Inhaled Corticosteroid by Pressurized Metered-Dose Inhaler. Presented at British Thoracic Society, England, December 6 – 8, 2017.

^[14] Nagel MW, Suggett JA. Equivalence evaluation of valved holding chambers (VHCs) with albuterol pressurized metered dose inhaler (pMDI). Presented at Respiratory Drug Delivery Europe, France 25-28 April 2017.

^[15] Mukherjee M, et al. The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases. BMC Medicine 2016;14:113.

^[16] Global Initiative for Asthma: Global strategy for asthma management and prevention, 2017  Available from: http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/Accessed January 2018.

^[17] Price D, et al. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respiratory Medicine. 2013;107(1):37–46.

^[18] Sanchis J, et al. Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest 2016;150:394–406

^[19] Health Improvement Scotland, British Thoracic Society. SIGN 153 • British guideline on the management of asthma. 2016 https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2016/ Accessed January 2018.

^[20] NICE – National Institute for Clinical Excellence, 2002, Inhaler devices for routine treatment of chronic asthma in older children (aged 5-15 years) Information for Patientshttps://www.nice.org.uk/guidance/ta38/resources/inhaler-devices-for-routine-treatment-of-chronic-asthma-in-older-children-aged-515-years-pdf-371430973 Accessed January 2018.

^[21] Levy ML, et al. Asthma patient’s inability to use a pressurized metered-dose inhaler (pMDI) correctly correlates with poor asthma control as defined by the Global Initiative for Asthma (GINA) strategy: a retrospective analysis. Prim Care Respir J. 2013; Dec;22(4):406-11.

^[22] Lavorini F, Fontana GA. Targeting drugs to the airways: The role of spacer devices. Expert Opinion on Drug Delivery. 2009;6(1):91-102.

^[23] Mitchell JP, et al. Electrostatics and inhaled medications: influence on delivery via pressurized metered-dose inhalers and add-on devices. Respiratory Care. 2007;52(3):283-300.

^[24] Items dispensed by Pharmacy and Appliance Contractors (PAC) in England, October 2017 https://www.nhsbsa.nhs.uk/prescription-data/dispensing-data/prescription-cost-analysis-pca-data Accessed January 2018.

^[25] Ammari WG, et al. Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma. J Asthma 2015;