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

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: http://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

Landmark Asthma Study Demonstrates Device Choice Determines Asthma Control

Monaghan Medical Corporation understands that for those with asthma, particularly children, choosing the device that best delivers their medication is an important consideration.

Plattsburgh, NY, USA — Monaghan Medical Corporation understands that for those with asthma, particularly children, choosing the device that best delivers their medication is an important consideration. Research has shown that even when using the same metered-dose inhaler (MDI), not all valved holding chambers perform equally well.[1]

A landmark real-world study involving more than 18,000 asthma patients has demonstrated superior asthma control with the AEROCHAMBER PLUS® FLOW-VU® antistatic Valved Holding Chamber (VHC) compared with other chamber devices.[2] According to the study, published in Pulmonary Therapy, use of the AEROCHAMBER PLUS® FLOW-VU® antistatic chamber resulted in delayed time to first exacerbation, fewer asthma-related emergency department visits, and lower exacerbation-related costs than control chambers.

Asthma is a common respiratory condition that affects an estimated 24.6 million people in the United States. Almost half of them, including nearly 3 million children, experience one or more asthma attack in a year.[3]

As opposed to systemic medications, inhalation is the recommended way to administer asthma medications because it directly targets the drug to the lungs while reducing potential side effects. Inhaled corticosteroids and bronchodilators administered by MDIs are the mainstay of long-term asthma treatment, the goals of which are to improve symptoms and prevent the occurrence of exacerbations.[4]

Poor inhaler operation by users is common, resulting in less of the delivered drug reaching the lungs. Instead, much of it is deposited on the back of the throat (oropharyngeal deposition) and then swallowed.[5] Research shows that between 28% and 68% of patients do not use inhalers well enough to benefit from prescribed medication.[6] In addition, 25% of costs associated with inhalers is wasted due to poor inhaler technique.[6]

Chambers are designed to reduce oropharyngeal deposition by changing the particle size distribution of the inhaled aerosol, and by holding the aerosol in the chamber until the patient is ready to inhale, which reduces the need for good coordination between inhalation and inhaler actuation.[7] Effectiveness of these devices can be adversely affected by the design, including the chamber electrostatic charge, a commonly reported cause of inconsistent medication delivery.[8]

Global respiratory guidelines recommend the use of chambers to improve MDI drug delivery.[4] American Thoracic Society and American Association for Respiratory Care Clinical Practice Guidelines state that the addition of a chamber is recommended and helpful.[9,10] Research also indicates that patients who use a chamber with an MDI have better asthma control than those using an MDI alone.[11]

In this new study, Dr. Chakkarin Burudpakdee (QuintilesIMS, Fairfax, VA, USA) and colleagues compared the effects of the antistatic AEROCHAMBER PLUS® FLOW-VU® aVHC and control chambers on treatment outcomes, resource use, and healthcare costs in a real-world asthma population.[2] More than 18,000 patients were included from an adjudicated claims database containing medical and pharmacy claims for more than 150 million U.S. health plan members.[2]

The analysis showed that among patients with at least 30 days of follow-up, those using the AEROCHAMBER PLUS® FLOW-VU® antistatic VHC experienced a delay in the time to first exacerbation and had fewer asthma-related emergency room visits. In addition, exacerbation-related costs were lower when compared to those using the control (non-antistatic) chambers.[2] A trend toward lower exacerbation rates per patient for the AEROCHAMBER PLUS® FLOW-VU® aVHC was sustained throughout the 12 months of the study.[2]

“This landmark study using a large volume of real-world evidence generated from thousands of patients shows the value of optimizing drug delivery in asthma management and further supports that chambers are not interchangeable,” said co-author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development. “The reduction in exacerbation incidents among users of the AEROCHAMBER PLUS® FLOW-VU® chamber is particularly notable because experiencing an exacerbation is a risk factor for future exacerbation events-and minimizing exacerbation risk is a key goal of treatment.”

“The European Medicines Agency recommended in 2009 that development of a MDI 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 said. “We presented laboratory data at the recent Respiratory Drug Delivery Europe meeting[2] that confirmed that not all chambers perform equally well with the same MDI, which underlines the importance of recognizing the impact and potential risks of substituting one device for another.”

About Monaghan Medical Corporation
Monaghan Medical Corporation (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, including the AEROCHAMBER PLUS® FLOW-VU® anti-static chamber
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 PLUS® valved holding chamber is the leading global chamber brand, with safety and efficacy validated in numerous third-party clinical evaluations among various patient populations. It is the chamber most recommended by leading MDI pharmaceutical companies.
• AEROCHAMBER PLUS® FLOW-VU® chamber is an antistatic chamber 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® 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® chamber with FLOW-VU® indicator versus the same chamber without the indicator.[12] The FLOW-VU® indicator provides real-time feedback confirming an effective inhalation and that there are no leakages of ambient air into the space between facemask and face, which could prevent medication delivery altogether. (http://www.monaghanmed.com/AeroChamber-Plus-Flow-Vu-aVHC2)

About the study
Data for more than 18,000 patients with an asthma diagnosis were analysed from the QuintilesIMS Real-World Data Adjudicated Claims Database (PharMetrics Plus) between 1/2010 and 8/2015-9,325 using the AEROCHAMBER PLUS® FLOW-VU® antistatic VHC and a propensity-matched comparison cohort of 9,325 non-antistatic VHCs. Exacerbation incident rates (IR), time to first exacerbation using Kaplan-Meier survival analysis, occurrence of exacerbations, and healthcare resource use and costs were compared.

• Exacerbation IR/100 person-days (95% CI) was significantly higher in the control device cohort than the antistatic chamber cohort (0.161 [0.150-0.172] vs.0.137 [0.128-0.147]); more patients in the antistatic chamber cohort remained exacerbation free.
• 4,293 patients in each cohort were followed up for (greater than or equal to)12 months, during which there was a trend for patients in the antistatic VHC group to be less likely (10-12%) to experience an exacerbation. Fewer patients using the antistatic VHC had an ED visit compared with those in the control group (10.8% vs. 12.4%).
• Exacerbation-related costs for the antistatic VHC cohort were 23%, 25%, 20%, and 12% lower than the control device cohort at 1, 6, 9, and 12 months, respectively.

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. © 2017 Monaghan Medical Corporation.

References

1 Nagel MW, Suggett JA. Equivalence evaluation of valved holding chambers (VHCs) with albuterol pressurized metered dose inhaler (pMDI). Respiratory Drug Delivery Europe; April 25-28, 2017, 2017; Nice, France.

2 Burudpakdee C, Kushnarev V, Coppolo D, Suggett J. A retrospective study of the effectiveness of the AeroChamber Plus® Flow-Vu® Antistatic Valved Holding Chamber for asthma control. Pulmonary Therapy. 2017. http://doi.org/10.1007/s41030-017-0047-1. Accessed July 14.

3 Asthma Facts. United States Environmental Protection Agency. EPA-402-F-04-019. May 2017.

4 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 November 2017.

5 Price D, Bosnic-Anticevich S, Briggs A, et al. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respiratory Medicine. 2013;107(1):37-46.

6 Fink JB, Rubin BK. Problems with Inhaler Use: A Call for Improved Clinician and Patient Education. Respir Care 2005;50(10):1360-74.

7 Lavorini F, Fontana GA. Targeting drugs to the airways: The role of spacer devices. Expert opinion on drug delivery. 2009;6(1):91-102.

8 Mitchell JP, Coppolo DP, Nagel MW. Electrostatics and inhaled medications: influence on delivery via pressurized metered-dose inhalers and add-on devices. Respiratory care. 2007;52(3):283-300.

9 Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. European Respiratory Journal 2014 ;43:343-373.

10 Ari A, et al. Aerosol Delivery Device Selection for Spontaneously Breathing Patients:2012. Respir Care 2012;57(4):613- 626.

11 Levy ML, et al. Asthma patients’ 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.

12 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; 52(3):301-7.

Monaghan Medical Corporation Receives Innovative Technology Designation from Vizient for the AEROBIKA® OPEP device

Designation recognizes products that bring improvements to the health care industry.

Plattsburgh, NY, USA — Monaghan Medical Corporation announced its AEROBIKA® Oscillating Positive Expiratory Pressure (OPEP) device has received a 2017 Innovative Technology designation from Vizient, Inc., the largest member-driven health care performance improvement company in the country. The designation was based on direct feedback from hospital experts who interacted with the AEROBIKA® OPEP device at the Vizient Innovative Technology Exchange in Denver on Sept. 14, 2017.

The AEROBIKA® OPEP device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients,1 and a real-world study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period.2 These improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) equate to a cost savings of $553 per patient with the AEROBIKA® OPEP device compared with no OPEP/PEP use, making the device a cost-effective treatment for COPD patients.

“We are extremely pleased to have been awarded this prestigious recognition from Vizient,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development. “Our device was recommended by Vizient members, which is a validation of all of the design and clinical work we have done to support our customers. We are the only OPEP device to have received this designation at this year’s Innovative Technology Exchange, and are proud it was recognized to deliver improved outcomes and enhanced safety.”

“Based on feedback from attendees at the Vizient Innovative Technology Exchange, it was determined that the AEROBIKA® OPEP device should be recognized with an Innovative Technology designation. This designation will be noted in our online member contract catalog. Congratulations to Monaghan Medical Corporation on receiving this status,” said Debbie Archer, director of procurement and Vizient Innovative Technology Program lead.

Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $100 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to review potentially innovative products. If it is determined that a product is innovative, Vizient may award a contract outside of the competitive bid cycle.

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, directly and through distributors, in the United States. MMC’s strength lies in its commitment to product quality, outcome based solutions for customers, and its collaboration with a state-of-the-art aerosol research laboratory. (http://www.monaghanmed.com)

1. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
2. Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of 30-day exacerbation outcomes in chronic obstructive pulmonary disease (COPD) patient managed with Aerobika OPEP. Pulmonary Therapeutics. 2017.

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