Significant Reductions in Costly Pulmonary Complications with Use of Drug-Free Device

Plattsburgh, NY, USA — Post-operative pulmonary complications (PPCs) are a major burden to the healthcare system. A new real-world study published in Pulmonary Therapy, indicates significant reductions in costs when using the AEROBIKA® oscillating positive expiratory pressure (OPEP) device in the postoperative care setting.(1) The retrospective database analysis including 288 patients undergoing cardiac, thoracic or upper abdominal surgery suggests that use of the AEROBIKA® OPEP device in addition to standard of care (incentive spirometry, IS) was associated with fewer re-hospitalizations, shorter hospital stays and lower costs compared with patients using standard of care alone.

At 30 days post-discharge, significantly fewer patients in the AEROBIKA® OPEP device cohort were re-hospitalized (13.9 vs. 22.9%; p=0.042), and mean length of hospital stay was significantly shorter (1.25±4.04 days vs. 2.60±8.24 days; p=0.047) compared with the IS cohort. Costs due to hospitalizations were 80% lower in the AEROBIKA® OPEP device group (p=0.001).

The burden of PPCs, especially in patients undergoing abdominal, thoracic or cardiac surgery, is substantial:

• death rate is higher compared with patients who don’t have PPCs (at 30 days mortality is up to 10 times higher, and at 90 days up to 20 times higher)

• resource use and costs are significantly increased (mainly due to longer length of hospital stay); a US database study of over 700,000 patients predicted that PPCs could lead to an additional 9,500 deaths, 92,000 extra ICU admissions and overall added costs to the US of US$3.42 billion.(2)

The causes of PPCs may be related to, among other things, shallow breathing and reduced airway clearance, therefore physical therapy techniques that increase lung volume and clearance have been recommended to reduce the risk and severity of PPCs. One such technique is incentive spirometry (IS), which encourages the patient to take long, slow breaths by inhaling through a device to raise a ball or piston.(3) The use of IS is common in clinical practice although there appears to be little evidence to support its value.(3,4) Another commonly used intervention to prevent and treat PPCs is positive expiratory pressure (PEP) therapy, which involves breathing against expiratory resistance.

The AEROBIKA® OPEP device is an easy-to-use, drug-free oscillating positive expiratory pressure (OPEP) device; when the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways and helps expel mucus to the upper airways where it can be coughed out. Clinical trial and real-world data have shown that the AEROBIKA® OPEP device increases lung volume, reduces hyperinflation and improves airway clearance in patients with COPD(5) or bronchiectasis,(6) as well as reducing exacerbations in patients with COPD.(7) These observations suggested a potential value for the device in preventing PPCs, leading the authors to conduct this retrospective real-world database study.

Co-author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development, commented that “based on the study findings, and taking into consideration both the low cost and low risk safety profile of the AEROBIKA® OPEP device, I would suggest that it could be beneficial to include as standard of care in all such post-operative patients”, noting that future studies are warranted to further define the benefits. He went on to add “The fact that patients in the AEROBIKA® OPEP device group in our study incurred lower healthcare costs in the 30-day period following discharge (mainly as a result of fewer complications requiring readmission) is particularly relevant as providers and insurers look to reduce early rehospitalization.”

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® OPEP 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 the AEROBIKA® Device
The AEROBIKA® OPEP device (http://www.monaghanmed.com/aerobika) is a hand-held, robust, easy-to-use, drug-free oscillating positive expiratory pressure (OPEP) device designed to help expel mucus from the lungs, expand airways and enhance drug deposition. When the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out. The AEROBIKA® OPEP device is designed to function independent of angle of use or flow rate, and allows for a direct aerosol pathway for patients using a nebulizer for medication delivery. The AEROBIKA® OPEP device has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George’s Respiratory Questionnaire (SGRQ) score in COPD patients.(8) The AEROBIKA® OPEP device is available in the US via Monaghan Medical Corporation, and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International (http://www.trudellmed.com). (http://www.monaghanmed.com/Aerobika-OPEP)

About the study
This retrospective database study utilized patient data stored in IQVIA’s proprietary Hospital Charge Detail Master (CDM) database. The CDM database manages daily transactional patient charges from over 650 hospitals from 46 states in the USA, covering 7 million annual inpatient stays and 60 million annual outpatient visits. A total of 887 cardiac, thoracic or upper abdominal surgery patients hospitalized between 1 September 2013 and 30 April 2017 were identified to have used the AEROBIKA® OPEP device (in addition to standard of care, incentive spirometry), of whom 144 matched the selection criteria. The comparison cohort was 144 propensity-score matched subjects who had used IS alone.

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. © 2018 Monaghan Medical Corporation.

1. Burudpakdee C, Near AM, Huang H, Coppolo D, Kushnarev V, Suggett J. A Real-World Evidence Study Assessing the Impact of Adding the Aerobika® Oscillating Positive Expiratory Pressure Device to Standard of Care Upon Healthcare Resource Utilization and Costs in Post-Operative Patients. Pulmonary Therapy. 2018.
2. Linde-Zwirble W, Bloom J, Mecca R, Hansell D. Postoperative pulmonary complications in adult elective surgery patients in the US: severity, outcomes and resources use. Critical Care. 2010;14 (Suppl 1):P210.
3. Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respiratory care. 2011;56(10):1600-1604.
4. Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Revista brasileira de fisioterapia (Sao Carlos (Sao Paulo, Brazil)). 2011;15(5):343-350.
5. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
6. Svenningsen S, Guo F, McCormack DG, Parraga G. Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging. Academic radiology. 2017;24(1):4-12.
7. 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.
8. Khoudigian-Sinani S, Kowal S, Suggett JA, Coppolo DP. Cost-effectiveness of the Aerobika® oscillating positive expiratory pressure device in the management of COPD exacerbations. International journal of chronic obstructive pulmonary disease. 2017;12:3065-3073.

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.

Significant Cost Reduction in COPD Care With Simple, Drug-free Device

Aerobika® OPEP device proves to be a cost-effective treatment option in the management of post-exacerbation COPD patients.

Plattsburgh, NY, USA — The Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device (Monaghan Medical Corporation) is a cost-effective treatment option in the management of COPD exacerbations, according to a study published October 20th in the International Journal of COPD.[1] This study, which used data from the published literature and national fee schedules to model the cost-effectiveness of the Aerobika® OPEP device, shows that it provides both clinical benefit and direct medical cost savings in a post-exacerbation care COPD population.

COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver.[2] Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold[3], and many patients experience two or three exacerbations every year.[4] As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days.[5]

The economic burden on the healthcare system associated with COPD is significant; in the US alone, the cost of COPD in 2010 was estimated to be US $50 billion; $30 billion in direct healthcare expenditure, with the remainder accounted for by indirect costs such as productivity losses and costs to families.[6] Approximately half of the direct costs could be accounted for by hospital care for COPD exacerbations,[6] which supports the GOLD guideline treatment goals of minimizing the negative impact of exacerbations and preventing recurrences.[2] Healthcare systems in many countries acknowledge the problem, and policies are now being put in place to try to address it; the US Medicare Hospital Readmission Reduction Program penalizes hospitals for excess 30-day, all-cause readmissions after a hospitalization for an acute exacerbation of COPD.[7]

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,[8] and a recent real-word study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period.[9] Using data from the latter study to provide real-world input, the authors of this current analysis showed cost savings ($553 per patient) and improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) with the Aerobika® OPEP device compared with no OPEP/PEP use, and concluded that the device provides cost-effective treatment for post-exacerbation COPD patients.

The authors also used various scenarios to investigate the likelihood of the benefit continuing over a full year, and predicted further clinical and cost benefits (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). Author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development noted, “Our model provides evidence of clinical and cost benefits of the Aerobika® OPEP device in that critical 30-day period following an exacerbation. Given the high burden of COPD – in particular, costs relating to exacerbations – in the US population, we would expect that even a small benefit would have a significant impact on the healthcare system”. He went on to say that, although further studies would be needed to validate the long-term effectiveness, these data also give a good indication that the benefits will be sustained with long-term use.

“With the increasing pressure to improve care and reduce hospital admissions, the previously-published real-world study showing exacerbation reductions in the critical 30-day post exacerbation period gave us useful insights into the benefits of integrating the Aerobika® OPEP device into standard clinical practice”, noted Dr Jason Suggett (Group Director of Global Science and Technology, TMI). “This new analysis now gives us clear evidence that such clinical benefits would be translated into cost-effectiveness in this post-exacerbation population. In addition, new data presented at CHEST 2017 demonstrating that the generation of the proprietary pressure/oscillation pattern of the Aerobika* device efficiently generates oscillations throughout a high percentage of each exhaled breath, and with consistently high pressure amplitudes. The Aerobika* device demonstrated efficient and effective performance related to therapeutic effectiveness nearly twice that of other devices tested.”[10]

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 (http://www.monaghanmed.com/aerobika) 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.

About the Aerobika® device
The Aerobika® OPEP device (http://www.monaghanmed.com/Aerobika-OPEP) is a hand-held, robust, easy-to-use, drug-free oscillating positive expiratory pressure (OPEP) device designed to help expel mucus from the lungs, expand airways and enhance drug deposition. When the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out. The Aerobika® OPEP device is designed to function independent of angle of use or flow rate, and allows for a direct aerosol pathway for patients using a nebulizer for medication delivery. The Aerobika® OPEP device has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George’s Respiratory Questionnaire (SGRQ) score in COPD patients.[8] The Aerobika® OPEP device is available in the US via Monaghan Medical Corporation (http://www.monaghanmed.com), and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International (http://www.trudellmed.com).

About the study
A one-year Markov model was used to estimate the cost-effectiveness of the Aerobika® OPEP device in patients who had experienced an exacerbation in the previous month, or a post-exacerbation care population, with input data from the published literature and national fee schedules. Using a base-case assumption that the benefit of the Aerobika® OPEP device would last 30 days, cost-savings ($553 per patient) and improved outcomes (ie, 6 fewer exacerbations per 100 patients per year) were demonstrated when compared with no OPEP/positive expiratory pressure use. Assuming a scenario with effect beyond the conservative 30 day time frame, the Aerobika® OPEP device continued to show benefit (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). One-way sensitivity analyses were conducted for all input variables, increasing or decreasing the effect by 20%, to determine the impact of change on costs and health effects; the results supported the robustness of the base-case conclusions.

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.

1. Khoudigian S, Kowal S, Suggett J, D. C. Cost-effectiveness of the Aerobika* oscillating positive expiratory pressure device in the management of COPD exacerbations. International journal of chronic obstructive pulmonary disease. 2017;In Press.
2. Global strategy for the diagnosis, management and prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
3. Khakban A, Sin DD, FitzGerald JM, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291.
4. Puhan MA, Chandra D, Mosenifar Z, et al. The minimal important difference of exercise tests in severe COPD. Eur Respir J. 2011;37(4):784-790.
5. Guerrero M, Crisafulli E, Liapikou A, et al. Readmission for Acute Exacerbation within 30 Days of Discharge Is Associated with a Subsequent Progressive Increase in Mortality Risk in COPD Patients: A Long-Term Observational Study. PLoS One. 2016;11(3):e0150737.
6. Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. Clinicoecon Outcomes Res. 2013;5:235-245.
7. Shah T, Press VG, Huisingh-Scheetz M, White SR. COPD Readmissions: Addressing COPD in the Era of Value-based Health Care. Chest. 2016;150(4):916-926.
8. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
9. 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.
10. Meyer A and Suggett J. A Laboratory Assessment into the Efficiency and Effectiveness of Different Oscillating Positive Expiratory Pressure Devices by Means of Patient Simulated Expiratory Waveforms. Presented at CHEST 2017.

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

Monaghan’s Drug-Free Aerobika® Device Helps Reduce the Real-World Impact of Exacerbations in Chronic Obstructive Pulmonary Disease

This study provides the first real-world evidence for the benefits of using the Aerobika® device in reducing exacerbation-related emergency department visits and hospital readmissions.

monaghan-medical-corporation-logo

Syracuse, NY, USA — Monaghan Medical Corporation (MMC) (http://www.monaghanmed.com), today announced the publication of a study in Pulmonary Therapy showing that treatment with Monaghan’s Aerobika® device can significantly reduce the recurrence of exacerbations of chronic obstructive pulmonary disease (COPD) in the crucial 30-day period following hospitalization or emergency room visits.(1) The study also showed that per-patient cost of exacerbations was significantly lower in the group using the Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device. This study provides the first real-world evidence for the benefits of using the Aerobika® device in reducing exacerbation-related emergency department visits and hospital readmissions.

COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver. Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold(2), and many patients experience two or three exacerbations every year.(3-5) As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days.(6)

This retrospective study analyzed hospital database records for 810 COPD Chronic Bronchitis patients who were hospitalized or visited the emergency room, and showed significantly fewer patients given the Aerobika® device experienced moderate-to-severe exacerbations or severe exacerbations compared with matched controls within the critical 30-day follow-up period. The study also showed a statistically significant savings in exacerbation-related costs in the Aerobika® device group compared with the control group for moderate-to-severe and severe exacerbations. The Aerobika® device was given in addition to the patients’ regular COPD treatments.

“This is the first study to evaluate the benefits of any OPEP in a real-world setting. It provides encouraging evidence that the Aerobika® device can help reduce recurrence of exacerbations in high-risk patients over the crucial early 30-day period,” noted Dr. Michael Bauer, Pulmonary Physician, Cooperstown, New York.

Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical, explained how the Aerobika® device may provide these benefits: “During an exacerbation, airways are compromised by (among other factors) inflammation and mucus build-up. This can continue to disrupt ventilation mechanics and lung function after the event, and lead to prolonged respiratory impairment. The Aerobika® device, with its proprietary mechanism of action, helps stent open and clear excess mucus from the upper airways, and may also aid drug deposition, providing a potential mechanism of protection from exacerbations.”

The internationally-recognized GOLD guidelines(7) for COPD treatment stress the importance of exacerbation management, stating that a major treatment goal is to ‘minimize the negative impact of the current exacerbation and to prevent subsequent events.’ A recent analysis(2) predicts that the absolute number of COPD cases could increase by between 150% and 220% in the period from 2010 to 2030, with the burden of inpatient care (total annual inpatient days) growing by around 185%. This further underlines this need to address the burden of COPD exacerbations.

About the Aerobika® device study
A retrospective cohort study utilizing patient data from the U.S. hospital Charge Detail Master (CDM) claims database (data selection period between 1 September 2013 and 31 August 2015). This real-word study involved 810 COPD patients with a diagnosis of chronic bronchitis, 405 receiving treatment with the Aerobika® device and 405 matched controls, (propensity matched to reduce bias and mimic randomization). The data showed significantly fewer patients given the Aerobika® device experienced moderate-to-severe exacerbations (18.5% vs 25.7%, p=0.014) or severe exacerbations (13.5% vs 19.0%; p < 0.046) compared with matched controls over the 30-day follow-up period, with consequent reductions in costs.

About the Aerobika® Device
The Aerobika® device is hand-held, robust, easy-to-use, and drug-free with a proprietary mode of action. When the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out, and may also aid in improved drug deposition. The Aerobika® device is designed to function independent of angle of use or flow rate, and allows for a direct aerosol pathway for patients using a nebulizer for medication delivery. The Aerobika® device has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ) score in COPD patients.(8) The Aerobika® device is available in the U.S. from Monaghan Medical Corporation, and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International. (http://www.monaghanmed.com/Aerobika-OPEP)

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)

References:

1. Burudpakdee C et al. Pulm Ther 2017 DOI 10.1007/s41030-017-0027-5. Pub online 6 February 2017.

2. Khakban A, et al. Am J Respir Crit Care Med 2017 Feb 1;195(3):287-291.

3. Balter MS, et al. Can Respir J 2003; 10 (Suppl B):3B-32B.

4. Perera PN, et al. COPD J Chron Obst Pulm Dis 2012;9(2):131-41.

5. Puhan MA, et al. Respir Res 2005;6 (1): 1.

6. Shah T, et al. Chest. 2016 Oct;150(4):916-926.

7. The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org (Last accessed 2 Feb 2017).

8. Svenningsen S, et al. COPD 2016;13(1):66-74.

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

New Study Indicates Monaghan Medical’s Drug-Free Aerobika® Device Shows Promise for Treatment of Bronchiectasis

This latest study adds to the growing base of evidence that demonstrates Monaghan’s drug-free Aerobika® device is effective for lung health maintenance.

monaghan-medical-corporation-logo

Syracuse, NY, USA — Monaghan Medical Corporation (MMC) today announced that the findings of a study published in the most recent issue of Academic Radiology shows that patients with non-cystic fibrosis (CF) bronchiectasis responded favorably to airway maintenance therapy using the Aerobika® device. This latest study adds to the growing base of evidence that demonstrates Monaghan’s drug-free Aerobika® device is effective for lung health maintenance.

In this latest study, researchers noted significant improvements in ventilation function for a number of bronchiectasis patients after three weeks of using the Aerobika® device. There were no adverse events related to the use of the device reported during the study.(1)

Bronchiectasis is a condition in which the structure and function of the airways become permanently damaged, usually as the result of infection or other condition. Patients suffering from chronic bronchiectasis typically have trouble clearing mucus from airways and suffer from a repeating pattern of airway damage, mucus buildup, and recurrent infections. The result is typically a vicious cycle of decline, resulting in reduced air exchange in the smaller airways.

There are three primary goals in the successful treatment of bronchiectasis:

1. Treat any underlying conditions and lung infections
2. Remove mucus from the lungs, and
3. Prevent complications

“This most recent study just adds to the mounting clinical evidence that our Aerobika® device is effective for patients with bronchiectasis, COPD, and related respiratory disease,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical. “We are always pleased to see real-world findings that demonstrate the efficacy of our Aerobika® device in clearing mucus to improve lung function in patients with chronic bronchial ailments as well as high-risk COPD patients.”

Overlap between bronchiectasis and COPD

Researchers have observed overlap between bronchiectasis and other chronic airway diseases such as chronic obstructive pulmonary disease (COPD). Studies show that these types of patients tend to have higher rates of exacerbation and worse outcomes.(1) The overlap between bronchiectasis and COPD was highlighted in a recent study presented at the 2016 CHEST annual meeting in October. Investigators found that 92.7 percent of COPD patients who had experienced more than one exacerbation in the previous 12 months also had bronchiectasis.(2)

The results of the study published in Academic Radiology showing effectiveness in treating bronchiectasis patients using the Aerobika® device are in line with another 2016 real-world study presented at the European Respiratory Society (ERS) International Congress. Investigators found the Aerobika® device demonstrated a clinically significant reduction in exacerbations in as little as 30 days of treatment when used as an add-on to usual COPD medications.(3)

About the bronchiectasis Aerobika® device study
Fifteen participants with non-CF bronchiectasis and 15 age-matched healthy volunteers underwent spirometry, plethysmography, computed tomography (CT), and hyperpolarized (3) He magnetic resonance imaging (MRI). Bronchiectasis patients also completed a Six-Minute Walk Test, the St. George’s Respiratory questionnaire, and Patient Evaluation Questionnaire (PEQ), and returned for a follow-up visit after three weeks of daily oscillatory positive expiratory pressure (Aerobika® device) use. Supplementary data related to this study can be found at dx.doi.org/10.1016/j.acra.2016.08.021.

About the bronchiectasis and COPD overlap study
A retrospective study of the medical records of 961 stable COPD outpatients who were followed regularly during the period 2011-2015 at least twice/year. Complete medical records were found in 855 patients who were eligible for the analysis. Results were presented at the 2016 CHEST annual meeting.

The complete study can be found at http://journal.publications.chestnet.org/article.aspx?articleid=2568609

About the Aerobika® device real-world COPD study
A retrospective cohort study of the CDM hospital claims database was conducted between September 2013 and August 2015. The final study sample comprised of 810 patients; 405 received an Aerobika® device and 405 were propensity score matched. The study inclusion criteria were: =1 record pre-index, =1 record post-index, newly initiated on the Aerobika® device, =1 diagnosis of CB on/before index, =18 years old, no evidence of other PEP/OPEP anytime, with complete records. See more at: http://erj.ersjournals.com/content/48/suppl_60/PA3780

About the Aerobika® device
The Aerobika® device is hand-held, easy-to-use and drug-free. When the patient exhales through the device, intermittent resistance creates positive pressure and oscillations simultaneously, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out, and may also aid in improved drug deposition. The Aerobika® device is available in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International and in the US via Monaghan Medical Corporation. (http://www.monaghanmed.com/Aerobika-OPEP)

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)

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

References:
[1] Svenningsen S et al. Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging. Acad Radiol. January 2017; 24:1,4-12.
[2] Kosmas E, et al. Bronchiectasis in Patients With COPD: An Irrelevant Imaging Finding or a Clinically Important Phenotype? Chest. 2016;150(4_S):894A.
[3] Suggett J. A Retrospective Cohort Study Demonstrating the Impact of an OPEP Device on Exacerbations in COPD Patients with Chronic Bronchitis. Presented at ERS 2016. Eur Respir J. 2016;48:PA3780.