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