Patients with Severe Asthma Show Sustained Clinical
Improvement
MARLBOROUGH, Mass.,
Sept. 18, 2017 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) today announced results from a three year
follow-up cohort in its Post-FDA Approval Clinical Trial Evaluating
Bronchial Thermoplasty (BT) in Severe Persistent Asthma (PAS2)
study. The results showed that the 190 patients in the real-world
study achieved similar reductions in severe exacerbations,
hospitalizations and emergency room visits when compared to the 190
patients treated with BT in the pivotal randomized, sham-controlled
Asthma Intervention Research 2 (AIR2) trial.
The results, which were published in the European Respiratory
Journal, the peer-reviewed journal of the European Respiratory
Society, corroborate the AIR2 trial and demonstrate that the
findings translate into meaningful outcomes in real-world
practice. PAS2 study participants had asthma symptoms that
were less well-controlled than subjects in the AIR2 trial and
results from the study demonstrate that, following the last BT
treatment:
- The percentage of patients experiencing severe exacerbations
decreased from 74 to 40;
- The percentage of patients with a hospitalization for at least
one asthma symptom decreased from 15 to 7 percent;
- The percentage of patients with emergency room visits decreased
from 27 to 11; and that
- The percentage of patients using daily maintenance oral
corticosteroid medications decreased from 19 to 10.
"The PAS2 study confirms that BT is an effective, durable and
safe treatment in severe asthmatics that have poorer asthma control
at baseline compared to patients evaluated in previous clinical
trials, such as AIR2," said Geoffrey
Chupp, M.D., principal investigator and director, Yale
Center for Asthma and Airways Disease, Yale
University School of Medicine, New
Haven, Connecticut. "The PAS2 study is the first
large-scale, prospective study of BT performed in a post-market
setting and validates the positive results from the AIR2
trial."
PAS2 is a prospective, open-label study that consecutively
enrolled patients at 27 research centers in the United States and Canada. According to clinical guidelines from
the European Respiratory Society and American Thoracic Society, 95
percent of PAS2 participants are considered severe
asthmatics.1 In comparison to AIR2 patients, PAS2 study
participants were older, with more taking systemic steroids, had a
higher Body Mass Index (BMI), and were on higher doses of inhaled
steroids. In the 12 months prior to treatment with BT, PAS2 study
participants were also more likely than AIR2 patients to have
experienced both severe exacerbations, 74 versus 52 percent, and
hospitalizations, 15 versus 4 percent.
"The results of the PAS2 study confirm that treatment with BT
has an enormous and positive impact in every day clinical practice
and may relieve some of the burden that adults with severe asthma
face," said Art Butcher, senior vice
president and president, Endoscopy, Boston Scientific. "We will
continue to work to make sure that patients have access and
coverage for this established, important treatment that has been
shown to improve asthma-related quality of life."
Asthma affects more than 230 million people globally and
approximately 10 percent of cases are considered severe.
2,3 The Alair™ System for BT is
approved by the U.S. Food and Drug Administration (FDA) and has CE
Mark for adult patients with severe asthma that is not well
controlled with medication. It is the first non-pharmacologic,
device-based treatment for severe, persistent asthma. Studies have
shown that BT can reduce severe asthma attacks for at least 5
years.4 Earlier this year, initial positive outcomes
from the PAS2 full-study cohort were presented at the American
Thoracic Society International Conference in Washington, D.C.
- Chung, K F. "International ERS/ATS Guidelines On." TASK
FORCE REPORT, American Thoracic Society ERS/ATS GUIDELINES ON
SEVERE ASTHMA, 10 Apr. 2014,
www.thoracic.org/statements/resources/allergy-asthma/Severe-Asthma-CPG-ERJ.pdf+.
- WHO. Asthma Fact sheet N°307. April
2017. Available at:
http://www.who.int/mediacentre/factsheets/fs307/en/index.html
- "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
>.
- Wechsler M et al. J Allergy Clin Immunol. 2013
Dec;132(6):1295-302
About Boston Scientific
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