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