MARLBOROUGH, Mass.,
May 24, 2017 /PRNewswire/
-- Boston Scientific (NYSE: BSX) today announced positive
results from the Post Approval Clinical Trial Evaluating Bronchial
Thermoplasty (BT) in Severe Persistent Asthma (PAS2) study
evaluating patients treated with the
Alair™ System. The data, presented at
the American Thoracic Society International Conference in
Washington, D.C., demonstrate that
BT reduces complications in adult patients with severe persistent
asthma.
PAS2 is an open-label study that enrolled 284 patients at 27
research centers in the United
States and Canada. Study
participants have asthma that is not well controlled by inhaled
corticosteroids (ICS) and long-acting beta-agonists (LABA) and may
also rely heavily on additional maintenance medications including
oral corticosteroids (OCS) and biologics. At the beginning of
the study, PAS2 study participants were, on average, 45.7 years old
with a body mass index of 32.2 kg/m2, took mean ICS and
LABA doses of 2275 µg/day and 106 µg/day, respectively, with 19.4
percent utilizing OCS and 15.8 percent omalizumab. These measures
are significantly higher than in prior studies.
Overall, patients in the study showed marked clinical
improvement that was sustained for two years following
treatment. The data demonstrated that:
- The percentage of study participants that had at least one
severe asthma exacerbation decreased from 77.8 percent in the year
prior to treatment to 50.4 percent in year one and 46.4 percent in
year two;
- The percentage of patients who had asthma-related
hospitalizations decreased from 16.1 percent in the year prior to
BT to 8 percent and 7.3 percent in years one and two following
treatment;
- The percentage of patients with asthma-related ER visits
reduced from 29.4 percent in the year before BT to 18.3 percent and
14.5 percent in years one and two post-BT;
- By the second year following BT treatment, the percentage of
patients taking OCS to manage their asthma symptoms had decreased
by 39.2 percent from 19.4 percent pre-treatment to 11.8
percent.
PAS2 study participants will be followed for five years post
treatment to conduct further analysis.
"The findings of the PAS2 study provide important real-world
evidence that patients with poorly controlled severe asthma on high
doses of medications, including biologics, experience significant
and sustained improvements in asthma control following BT," said
Geoffrey Chupp, M.D., principal
investigator and director, Yale Center for Asthma and Airways
Disease, Yale University School of
Medicine, New Haven,
Connecticut. "These results reinforce previously published
data from randomized controlled studies and demonstrate that BT
delivered by the Alair System is both safe and effective for a wide
range of patients with severe asthma."
The Alair System for BT was approved by the U.S. Food and Drug
Administration (FDA) in 2010 and is the first non-pharmacologic,
device-based treatment for severe, persistent asthma. The Alair
System delivers controlled thermal energy to the airway wall to
reduce the amount of excess smooth muscle tissue in the
airways. With less smooth muscle, the airways constrict less,
reducing severe asthma attacks and making breathing
easier.
"Bronchial Thermoplasty is an established treatment that can
transform the lives of people with severe asthma," said
Art Butcher, senior vice president
and president, Endoscopy, Boston Scientific. "We are committed to
working with the healthcare community to ensure that patients with
severe asthma have access to this important treatment option."
Asthma is a chronic inflammatory disease of the airways
characterized by recurrent attacks of breathlessness and wheezing,
which vary in severity and frequency from person to person. Asthma
currently affects more than 25 million people and approximately 10
percent of cases are considered severe.1,2 For
those who suffer from severe asthma, even the highest dose of
standard medications may not alleviate the risk of frequent and
life-threatening asthma attacks. During an asthma attack, the
lining of the bronchial tubes swell, causing the airways to narrow
and reducing the flow of air in and out of the
lungs.3
- "Trends in Asthma Prevalence, Health Care Use, and Mortality in
the United States, 2001–2010."
Centers for Disease Control and Prevention. Centers for Disease
Control and Prevention, 01 May 2012.
Web. 05 May 2017.
<https://www.cdc.gov/nchs/products/databriefs/db94.htm>.
- "The Prevalence of Severe Refractory Asthma | AAAAI." The
American Academy of Allergy, Asthma & Immunology. The Journal
of Allergy and Clinical Immunology, Oct.
2014. Web. 05 May 2017.
<https://www.aaaai.org/global/latest-research-summaries/New-Research-from-JACI-In-Practice/refractory-asthma>.
- WHO. Asthma Fact sheet N°307. November 2013. Available
at: http://www.who.int/mediacentre/factsheets/fs307/en/index.html
(accessed December 2016).
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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CONTACTS:
Catherine
Brady
Media
Relations
508-683-4797
Catherine.Brady@bsci.com
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Investor Relations
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investor_relations@bsci.com
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SOURCE Boston Scientific Corporation