The Drug-free Aerobika* Device Helps Reduce the Real-world Impact of Exacerbations in Chronic Obstructive Pulmonary Disease

LONDON, Ontario, February 22, 2017 /PRNewswire/ --

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, according to a study published this month in Pulmonary Therapy.^[1] The study also showed that per-patient cost of exacerbations was significantly lower in the Aerobika* device group. 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. 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.

Jason Suggett, PhD, BPharm, MRPharmS (Group Director of Global Science and Technology at TMI), 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 guidelines^[7] 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] 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 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 Canada, Mexico (http://www.aerosolms.com ), Australia (http://www.airliquidehealthcare.com.au) and select European countries including the UK and Germany through Trudell Medical International and in the US via Monaghan Medical Corporation.

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 have been sold in over 110 countries. Their efficacy has been validated in numerous peer-reviewed publications.

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: Dr. Jason Suggett, Group Director, Global Science and Technology, [phone] ext. 2270