Study Results of Non-drug Device to Treat Bronchiectasis Show Promising Results for a Challenging Disease

LONDON, Ontario, January 5, 2017 /PRNewswire/ --

Trudell Medical International announced results from a study that evaluated the response to airway maintenance therapy using the Aerobika^® device in patients with non-cystic fibrosis (CF) bronchiectasis. Study results were published in the most recent issue of Academic Radiology, adding to the growing evidence base supporting the use of the Aerobika^® device in lung health maintenance.

About bronchiectasis 

Bronchiectasis (brong-ke-EK-ta-sis) is a condition in which the structure and function of the airways become permanently damaged. Bronchiectasis is usually the result of an infection or other condition that injures the walls of airways and prevents the airways from clearing mucus. There is a repeating pattern of airway damage, buildup of mucus, and recurrent infections. Each compounds the other, creating a vicious cycle of decline, resulting in reduced air exchange in the small airways.   

The goals of bronchiectasis treatment are to:

• Treat any underlying conditions and lung infections,
• Remove mucus from the lungs, and
• Prevent complications.

Aerobika^® device study results for bronchiectasis

In this latest study of bronchiectasis patients, researchers noted significant improvements in ventilation function for a number of the 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]

Dr. Jason Suggett, Group Director Science & Technology for Trudell Medical International agrees. "The current investigation-as well as recently reported studies-add to the growing evidence base demonstrating that the Aerobika^® device can help to improve the maintenance and function of the lungs of patients who have compromised airways by opening airways and clearing mucus."

Overlap between bronchiectasis and COPD 

Researchers have observed overlap between bronchiectasis and other chronic airway diseases such as COPD. They have reported 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. Investigators found that for COPD patients who had experienced more than one exacerbation in the previous 12 months, 92.7% also had bronchiectasis.^[2]

These results from 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 3 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.

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 yrs 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. TrudellMed.com/products/Aerobika

About Trudell Medical International (TMI)
TMI designs, develops and manufactures a wide range of high quality, innovative medical devices and is home to a global Aerosol Lab and Research Center. From the flagship AeroChamber^®Brand of Valved Holding Chambers (VHC) and the latest award-winning Aerobika^® device, to custom designed products and systems, many of our best-in-class respiratory management products are sold in over 110 countries and their efficacy has been validated in numerous peer-reviewed publications. TrudellMed.com

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.
[4] O'Donnell DE, Parker CM. COPD exacerbations • 3: Pathophysiology. Thorax 2006 61: 354-361. 
[5] Newall C, et al. Exercise training and inspiratory muscle training in patients with bronchiectasis. 2005;60:943-948.

For more information about the Aerobika® device and study results, contact Jason Suggett PhD, BPharm, MBA, MRPharmS, Group Director of Global Science and Technology, Trudell Medical International, +1-519-455-7060 ext. 2270