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. End Quote

(1888PressRelease) January 18, 2017 - 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.

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 (http://www.academicradiology.org/article/S1076-6332%2816%2930223-9/abstract).

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.

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