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.

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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.

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.

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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.

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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.

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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