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