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
