SUNNYVALE, CA -- 02/11/08 --
Asthmatx, Inc., a medical device company that
has developed a catheter-based procedure under investigation for the
treatment of asthma, announced today the publication of data from the
Research in Severe Asthma (RISA) Trial of bronchial thermoplasty in the
American Journal of Respiratory and Critical Care Medicine (AJRCCM, 2007;
176:1185-1191). The publication reports that despite a transient increase
in procedure-related adverse events, patients experienced longer-term
improvement in pulmonary function, improved quality of life and asthma
control, and a reduction in rescue medication use for patients treated with
bronchial thermoplasty.
Bronchial thermoplasty is a non-drug treatment for asthma and is currently
under clinical investigation. Bronchial thermoplasty is an investigational
procedure in which precisely controlled thermal energy is delivered with a
tiny catheter to targeted airway walls of patients with asthma. This
procedure is intended to reduce muscle in the walls of airways, and thereby
decrease the ability of airways to narrow in patients with symptomatic
asthma.
The RISA Trial was a randomized trial conducted at a total of eight centers
in three countries, and evaluated the safety and efficacy of bronchial
thermoplasty in a total of 32 adult subjects, randomized 1:1 between the BT
group and Control group with severe persistent asthma who were symptomatic
despite taking regular asthma medications.
In this group of patients with severe asthma, an increase in
respiratory-related symptoms was expected and observed during the period
immediately following the procedure. Most occurred within one day of the
procedure and resolved on average within a week. Following the treatment
period, respiratory-related symptoms were similar between treatment groups.
Almost 6 months after the procedure, compared to the control group,
patients who received bronchial thermoplasty showed clinically and
statistically significant improvements in pulmonary function, quality of
life and asthma control. In addition, patients in the treatment group used
an average of 25 fewer puffs per week of rescue medication than those in
the untreated Control group.
All patients then attempted to reduce their inhaled and/or oral
corticosteroids (OCS) during a 14-week period. Fifty percent (50%) of
bronchial thermoplasty treated patients were able to wean completely off
their oral corticosteroids (OCS), compared to 14% of patients who did not
receive the treatment. This improvement did not reach statistical
significance; however the study was not powered to show statistical
significance in medication changes.
One year following treatment, and after the period of medication reduction,
patients who received the bronchial thermoplasty procedure continued to
show clinically and statistically significant improvements in quality of
life and asthma control, and used less rescue medication.
"We found that, in this population of severe asthma patients, bronchial
thermoplasty was associated with a short-term increase in asthma-related
symptoms around the time of treatment but showed a potential for a
longer-term improvement in rescue medication use, lung function, asthma
control and quality of life," states Ian D. Pavord, MD and principle
investigator of the study at the Glenfield General Hospital, University
Hospitals of Leicester. "These potential long term improvements make us
hopeful that bronchial thermoplasty could some day be a viable new
treatment option for these severe asthma patients."
Current Research of Bronchial Thermoplasty
If you have asthma, are between 18 and 70 years of age, are a non-smoker,
and take medication daily to help control your asthma, you may be eligible
to participate in a future bronchial thermoplasty clinical study. For more
information on participation, please call the following toll-free number:
(866) 400-2472 or visit www.bronchialthermoplasty.com.
CAUTION: Alair System is an Investigational Device. It is limited by
United States law to investigational use. To be used by Qualified
Investigators only.
Alair is a registered trademark of Asthmatx, Inc.
Editor's Notes:
For more information on Asthmatx or the Alair Bronchial Thermoplasty
System, please contact Karen Passafaro at 408-419-0118 or
kpassafaro@asthmatx.com.
About Asthmatx:
Asthmatx is developing catheter-based medical devices for the treatment of
asthma. Asthmatx has developed the Alair System to perform an
investigational outpatient procedure called bronchial thermoplasty.
Bronchial thermoplasty involves the delivery of precisely controlled
thermal energy to the airway wall, to reduce the amount of airway smooth
muscle, and lessen these muscles' ability to narrow the airway. For more
information on Asthmatx visit www.asthmatx.com. The Alair System has
received a CE Mark to sell the device in the European Union.
Contact:
Karen Passafaro
Asthmatx
408-419-0118
Email Contact.
