Tag Archives: copd

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.

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’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.

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 Shows Monaghan Medical’s Drug-Free Aerobika® Device Reduces Acute Drug Usage and Costs Following COPD Exacerbations

Real-world study presented at CHEST 2016 Annual Meeting in Los Angeles.

Syracuse, NY, USA — Monaghan Medical Corporation (MMC) today announced that a new study presented to the American College of Chest Physicians (CHEST) shows MMC’s Aerobika® device is effective in reducing drug use for treatment of Chronic Obstructive Pulmonary Disease (COPD).

COPD is a major source of morbidity and mortality in the United States.(i) The Center for Disease Control estimates that COPD medical visits, hospital admissions and lost time costs 36 billion dollars annually.(ii) The recommended course of treatment for acute COPD exacerbations includes antibiotics and oral corticosteroids (OCS).(iii)

The study results revealed today at the CHEST Annual Meeting in Los Angeles, show that those study patients who used the Aerobika® device experienced a significant reduction (57% and 89% reduction, respectively) in the use of antibiotics and OCS in the hospital setting compared to those study patients who did not use the Aerobika® device in addition to the regular COPD medication treatment. These findings are part of a larger 6-month retrospective study that demonstrated a 28% reduction in exacerbations in as little as 30 days of treatment, when used as an add-on to usual COPD medications.

COPD exacerbations can be caused by viral or bacterial infections, in fact pulmonary infections are associated with 50% of COPD hospital admissions(iv) and higher mortality rates.(v) Overproduction of mucous leads to increased rates of infection and inflammation contributing significantly to morbidity and mortality in COPD.(vi)

This study showed for patients in the Aerobika® device cohort, antibiotics were used 57% less and oral corticosteroids were used 89% less than for the cohort without the Aerobika® device within 6 months’ post-exacerbation. The decreased need for short-term drug therapies including antibiotics and OCS, may have reflected better disease control with those patients who used the non-drug device. Additionally, patients in the Aerobika® device cohort exhibited significantly lower costs throughout the study period with an average reduction of $6,347 USD and $9,936 USD per patient at 30 days and 6 months respectively for all in-patient and out-patient hospital costs.

“One of our major goals in developing the Aerobika® device was to safely improve patient outcomes,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical. “These real-world findings are encouraging as we continue to conduct additional studies to further demonstrate the impact of our device in this high risk patient population.”

The projected cost of COPD in the U.S. by 2020 has been calculated at $49 billion.(vii) Since COPD exacerbations account for the greatest proportion of burden on healthcare systems,(viii) and readmissions are unwanted and expensive, the simplest way to reduce hospital admissions for COPD is to reduce exacerbations.(ix)

About the Aerobika® device study: A 6-month retrospective cohort study of the US hospital Charge Detail Master (CDM) claims database, conducted between September 2013 and 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 propensity score matched controls. The primary outcome was the proportion of patients with moderate-to-severe and severe exacerbations at 30 days. Secondary measures included resource utilization and costs associated with exacerbations.

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.trudellmed.com/products/aerobika)

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

COPD Facts in USA(x)
– More than 15 million people report being diagnosed with COPD but millions more may not have been diagnosed
– COPD accounts for 10.3 million medical visits and 1.5 million hospital admissions
– 23 percent of hospitalized patients are re-hospitalized within 30 days
– For COPD exacerbations, Medicare healthcare expenditures for re-hospitalization are the third highest
– The total cost of COPD hospitalizations is estimated at $36 billion per year

i Ford ES, et al. Chest 2013;144(1):284-305.
ii Ford ES, et al. Chest. 2015 Jan;147(1):31-45.
iii Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2015.
iv Tesfaigzi Y et al. Clinical and Applied Immunology Reviews 2006;6(1):21-36
v Burgel PR, Martin C. European Respiratory Review 2010;19(116):94-96.
vi Hogg JC et al. The Nature of Small-Airway Obstruction in Chronic Obstructive Pulmonary Disease The New England Journal of Medicine 2004;350(26):2645-2653
vii Ford ES, et al. Chest. 2015 Jan;147(1):31-45.
viii Khakban A, et al. Am J Respir Crit Care Med. 2016
ix Mittmann et al. Respir Med. 2008 Mar;102(3):413-21.
x Ford ES, et al, Chest. 2015 Jan;147(1):31-45.

Non-Drug Device Reduces COPD Exacerbations

Real-World Study Presented at ERS 2016, London UK.

Plattsburgh, NY, USA — Monaghan Medical Corporation (MMC) today announced results from a real-world study, evaluating the efficacy of the Aerobika® device in reducing chronic obstructive pulmonary disease (COPD) exacerbations. These results were presented at the European Respiratory Society International Congress in London, and are anticipated to impact the future management of COPD patients with a history of exacerbations.

Exacerbations are a worsening of symptoms and are the most common reason for COPD hospital admissions (1). During an exacerbation, airways are compromised by inflammation and mucus buildup, causing patients to be poorly responsive to usual COPD treatments (2). Recovery can be delayed for weeks, resulting in further airway deterioration and putting patients at risk of recurrent exacerbations. In fact, approximately 1 in 5 admitted patients required re-hospitalization within 30 days (3).

Clinicians, hospitals, and healthcare systems around the globe are now focusing their attention on this critical post-exacerbation period with the goal of reducing subsequent re-admissions and maintaining the long-term health of their COPD patients.

In the 6-month study, 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. “These results carry important implications for how we manage COPD patients with a history of exacerbations,” says Brian Carlin, MD, FCCP, FAASM. “Adding the Aerobika® device to our current COPD treatment protocols could significantly improve patient outcomes while decreasing the burden on our healthcare resources.”

The Aerobika® device has been previously validated in clinical studies, demonstrating improvements in airway ventilation, lung function and quality of life. “This new study has validated the use of this device in a real-world setting, providing a drug-free addition to post-exacerbation therapy for COPD patients.” says Dr. Jason Suggett, Group Director of Science & Technology at Trudell Medical International (TMI), the sister company for MMC.

About the Aerobika® device study
The study profiled here is a 6-month retrospective cohort study of the hospital Charge Detail Master (CDM) claims database, conducted between September 2013 and August 2015. This real-word study involved 810 patients, 405 receiving treatment with the Aerobika® device and 405 propensity score matched controls. The primary outcome was the proportion of patients with moderate-to-severe and severe exacerbations at 30 days. Secondary measures included resource utilization and costs associated with exacerbations.

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 stents open the airways, mobilizes and assists in moving mucus to the upper airways where it can be coughed out. This 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 TMI and in the US via Monaghan Medical Corporation. (http://www.monaghanmed.com/Aerobika)

About Monaghan Medical Corporation (MMC, USA)
MMC, an affiliate of TMI, offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® brand aVHC, and the Aerobika® device exclusively in the United States. Our strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. We focus on developing cost-efficient, outcome-based solutions for our customers. (http://www.monaghanmed.com)

About Trudell Medical International (TMI)
TMI designs, develops and manufactures a wide range of medical devices and is home to a global aerosol lab and research center. From the flagship AeroChamber® Brand of Valved Holding Chamber (VHC) and the latest award-winning Aerobika® device, to custom designed products and systems, our best-in-class respiratory management products are sold in over 110 countries. Their efficacy has been validated in hundreds of peer-reviewed articles from various medical journals. (http://www.trudellmed.com)

References:
[1] O’Donnell et al. Can Respir J. 2007;14(Suppl B):5B-32B.
[2] O’Donnell DE, Parker CM. Thorax. 2006;61(4):354-61.
[3] Shah et al. CHEST. 2016 May 7 [Epub ahead of print].

For clinical inquiries, please contact:
Jason Suggett, Group Director Science and Technology
Trudell Medical International
519-455-7060 ext. 2270