SYRACUSE, NY, 21 February, 2017 – Monaghan Medical Corporation (MMC) today announced the publication of a study in Pulmonary Therapy showing treatment with the AEROBIKA^® device can significantly reduce the recurrence of exacerbations of 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^® 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-fold², 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. Exacerbation-related costs also showed a statistically significant savings 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, and it provides encouraging evidence that the Aerobika^® device can help reduce recurrence of exacerbations in this high-risk group of 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, which can continue to disrupt ventilation mechanics and lung function after the event, and lead to prolonged respiratory impairment.” He noted that “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 guidelines⁷ 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 analysis² predicting 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% 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 US 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 US via Monaghan Medical Corporation, and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International. https://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^®FLOW-VU^® 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. https://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