Trudell Medical International: Non-drug device helps reduce antibiotic and oral corticosteroids usage following COPD exacerbations

Real-world study presented at CHEST 2016, Los Angeles, California

LONDON, ON, Oct. 27, 2016 /CNW/ - Acute exacerbations of COPD are the most common reason for medical visits, hospital admissions, and death in patients with COPDⁱ.  The recommended course of treatment for acute COPD exacerbations includes antibiotics and oral corticosteroids (OCS).ⁱⁱ The study results revealed Wednesday, October 26^th at the CHEST Annual Meeting in Los Angeles, show that those study patients who used the Aerobika^® device experienced a significant reduction (57% and 89% reduction, respectively) in the use of antibiotics and OCS in the hospital setting compared to those study patients who did not use the Aerobika^® device in addition to the regular COPD medication treatment.  These findings are part of a larger 6-month retrospective study that demonstrated a 28% reduction in exacerbations in as little as 30 days of treatment, when used as an add-on to usual COPD medications.

COPD exacerbations can be caused by viral or bacterial infections, in fact pulmonary infections are associated with 50% of COPD hospital admissionsⁱⁱⁱ and higher mortality rates^iv. Overproduction of mucous leads to increased rates of infection and inflammation contributing significantly to morbidity and mortality in COPD.^v

This study showed for patients in the Aerobika^® device cohort, antibiotics were used 57% less and oral corticosteroids were used 89% less than for the cohort without the Aerobika^® device within 6 months post-exacerbation.  The decreased need for short-term drug therapies including antibiotics and OCS, may have reflected better disease control with those patients who used the non-drug device.  Additionally, patients in the Aerobika^® device cohort exhibited significantly lower costs throughout the study period with an average reduction of $6,347 USD and $9,936 USD per patient at 30 days and 6 months respectively for all in-patient and out-patient hospital costs.  "One of our major goals in developing the Aerobika^® device was to safely improve patient outcomes," says Jason Suggett, PhD, BPharm, MRPharmS, Group Director of Global Science and Technology at TMI. "These real-world findings are encouraging as we continue to conduct additional studies to further demonstrate the impact of our device in this high risk patient population."

With COPD prevalence expected to rise 155% by 2030, there is predicted to be an epidemic of COPD hospitalizations over the next 15 years^vi. Since COPD exacerbations account for the greatest proportion of burden on healthcare systems^vii any intervention aimed at reducing the burden of COPD needs to be adopted urgently as stated in the recent American Thoracic Journal Articles in Press.^viii

About the Aerobika^® device study:  A 6-month retrospective cohort study of the US hospital Charge Detail Master (CDM) claims database, conducted between September 2013 and 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 propensity score matched controls. The primary outcome was the proportion of patients with moderate-to-severe and severe exacerbations at 30 days. Secondary measures included resource utilization and costs associated with exacerbations.

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. https://www.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 Chamber (VHC) and the latest award-winning Aerobika^® device, to custom designed products and systems, our best-in-class respiratory management products are sold in over 110 countries. Their efficacy has been validated in numerous peer-reviewed publications. https://www.trudellmed.com/

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COPD Facts in Canada

• More than 800,000 people are diagnosed with COPD^ix
• Acute exacerbations are the most common reason for medical visits, hospital admissions, and death in patients with COPD^x
• About one in five patients with an index condition of COPD (18.8%) were readmitted to acute inpatient care within 30 days^xi
• An estimated 8% of exacerbating patients die in hospital at any time, and 25% die within one year of being hospitalized^xii
• The total cost of COPD hospitalizations is estimated at $1.5 billion per year^xiii
• Hospital stays for COPD exacerbations lasted an average of 10 days at $10,000 per stay^xiv

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ⁱ O'Donnell et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2007 update. Can Respir J. 2007;14(Suppl B):5B-32B
ⁱⁱ Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2015.
ⁱⁱⁱ Tesfaigzi Y et al. Clinical and Applied Immunology Reviews 2006;6(1):21-36.
^iv Burgel PR, Martin C. European Respiratory Review 2010;19(116):94-96.
^v Hogg JC et al. The Nature of Small-Airway Obstruction in Chronic Obstructive Pulmonary Disease The New England Journal of Medicine 2004;350(26):2645-2653
^vi Khakban A, et al. The Projected Epidemic Of COPD Hospitalizations Over the Next 15 Years: A Population Based Perspective Am J Respir Crit Care Med. 2016
^vii Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2015.
^viii Khakban A, et al. The Projected Epidemic Of COPD Hospitalizations Over the Next 15 Years: A Population Based Perspective Am J Respir Crit Care Med. 2016
^ix Statistics Canada. Chronic obstructive pulmonary disease by age group and sex (Number). Available at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01 /health 104a-eng.htm. CANSIM table 105-0501
^x .O'Donnell et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2007 update. Can Respir J. 2007;14(Suppl B):5B-32B
^xi All Cause Admission to Acute Care, CIHI 2012  https://secure.cihi.ca/free_products/Readmission_to_acutecare_en.pdf
^xii Canadian Thoracic Society. The Human and Economic Burden of COPD: A Leading Cause of Hospital Admission in Canada. February 2010
^xiii Canadian Thoracic Society. The Human and Economic Burden of COPD: A Leading Cause of Hospital Admission in Canada. February 2010
^xiv Canadian Thoracic Society. The Human and Economic Burden of COPD: A Leading Cause of Hospital Admission in Canada. February 2010

SOURCE Trudell Medical International

For clinical inquiries, please contact: Jason Suggett PhD, BPharm, MBA, MRPharmS, Group Director of Global Science and Technology, 519-455-7060 ext. 2270